Consolidated List of US FDA Guidelines Published in 2022
Period: January 2022 to December 2022
The U.S. Food and Drug Administration (FDA) is a federal agency that is responsible for protecting and promoting public health through the regulation of drugs, medical devices, and other products. The FDA has established a set of guidelines that pharmaceutical companies must follow when developing, testing, and marketing their products. These guidelines are designed to ensure the safety, efficacy, and quality of pharmaceutical products, and to provide consumers with accurate and reliable information about these products.
One of the main purposes of the FDA guidelines for the pharmaceutical industry is to ensure that new drugs are thoroughly tested for their safety and effectiveness before they are made available to the public. This process involves conducting clinical trials to evaluate the safety and efficacy of a new drug, and submitting the results of these trials to the FDA for review and approval. The FDA also has the authority to recall or withdraw a drug from the market if it is found to be unsafe or ineffective.
In addition to regulating the development and marketing of new drugs, the FDA also has guidelines in place for the manufacturing and distribution of pharmaceutical products. These guidelines are designed to ensure that pharmaceutical products are consistently manufactured and distributed according to good manufacturing practices, and that they meet the quality standards established by the FDA.
Overall, the FDA guidelines for the pharmaceutical industry play a critical role in ensuring the safety and effectiveness of the drugs that are available to the public.
Following are the Consolidated List of US FDA Guidelines published in the year 2022.
| Name of Guidance | Date | Objective of the guideline | FDA Link |
|---|---|---|---|
| Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry (draft) | January 25, 2022 | (1) To help industry and ANDA holders in updating their labeling based on revisions of a reference listed drug (RLD) labeling. (2) Helps to identify updates on revision of RLD labeling and submission requirements for ANDA holders. | Link |
| Patient Engagement in the Design and Conduct of Medical Device Clinical Studies | January 26, 2022 | (1) Engagement of patient volunteer to improve the design of medical device (2) Advantages of above approach of using patient volunteer (3) Criteria for selection of patient volunteer (4) Q&A about misconceptions regarding collecting and submitting patient engagement information to the FDA | Link |
| Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation | January 26, 2022 | (1) To provide principles that can be used while Patient-reported outcome (PRO) uses instruments for the evaluation of medical devices; (2) Provide guidance about the significance of assuring the PRO instruments are fit for the intended use. (3) Provides brief about best practices to develop, modify, or adapt reliable, relevant, and sufficiently robust PRO instruments and using the minimum difficult approach. | Link |
| Principles of Premarket Pathways for Combination Products | January 26, 2022 | (1) General and high-level information about combination products (2) How to coordinate and interact with FDA regarding combination product regulation (3) Approach of FDA while reviewing the combination products before they are marketed. (4) How to determine the type of premarket submissions that is appropriate for combination products. | Link |
| Information Requests and Discipline Review Letters Under GDUFA | January 26, 2022 | (1) Provide explanation about issuance and use IR (information request) and a DRL (discipline review letter) during the assessment of ANDA. (2) Amendment to a supplement, supplement and amendment made in response to a CRL (complete response letter) does not covered under scope of this guidance. (3) Commitment of FDA on performance goals for acting on received ANDAs (4) Committed of FDA to provide preliminary thoughts on possible deficiencies when discipline finishes its initial assessment. | Link |
| Good ANDA Submission Practices | January 26, 2022 | (1) Assist applicants in preparing to submit ANDAs. (2) Provides an idea about common and recurring deficiencies to prevent delay in the approval of an ANDA. (3) Provides recommendations that how to prevent such deficiencies that helps early approval. | Link |
| Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs (Draft) | February 01, 2022 | The guidance describes the process and mechanism for formal meetings between FDA and sponsors for an OTC drug. This guidance describes the method how sponsors can receive suggestion on studies to support their applications, types of meeting, formats of meeting, process of sponsors request, timelines of agency response on the meeting requests, package of meeting, and process of cancellation and rescheduling the meetings. | Link |
| Population Pharmacokinetics | February 03, 2022 | The purpose of this guideline is to support new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drugs (IND) applicants and sponsors with respect to population for pharmacokinetic (PK) analysis. | Link |
| Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry (Draft) | February 07, 2022 | The purpose of the graft guidance is: To provide recommendations and assist industries and parties involved in the development of antibody-drug conjugates (ADCs) with a cytotoxic small molecule drug or payload. The guidance reflects the FDAs current thinking on Clinical pharmacology considerations Recommendations for development that includes bioanalytical methods, dosing strategies, dose- and exposure-response analysis, intrinsic factors, QTc assessments, immunogenicity, and drug-drug interactions (DDIs). Specific emphasize on clinical pharmacology considerations of ADC development programs with appropriate reference. | Link |
| COVID-19 Public Health Emergency Policy on COVID-19-Related Sanitation Tunnels | February 08, 2022 | Purpose of this policy document is FDA’s concerns regarding safety of human. The guidance discourages development, approval, and usage authorization for sanitation tunnels (also called as disinfection/ sanitizing tunnels) | Link |
| FDA released its latest quarterly batch of product specific guidance (PSGs) to support generic drug development | February 18, 2022 | As per FDA notice the guidance “provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs)”. | Link Link |
| Patient-Focused Drug Development: Methods to Identify What Is Important to Patients | February 25, 2022 | The objective of this guidance is to describe how stakeholders such as researchers, patients, medical product developers, and others should collect and submit the data that is related to the patient experience and other associated information from patients and caregivers. This is the second guideline in a series of four guidelines to provide methodological Patient Focused Drug Development. | Link |
| Pre-Launch Activities Importation Requests (PLAIR) | March 01, 2022 | The objective of this guidance is to describe the FDA’s policy about importation requests of unapproved drug products by applicants of NDA, and ANDA who is preparing for product launch in U.S. market based on anticipated approval. The guideline is also applicable for biologics licensing applications (BLAs) for which NDA, BLA, or ANDA approval is anticipated. | Link |
| Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C | March 03, 2022 | The objective of this FDA guidance is to provide clarity on FDA’s expectation from industry and FDA staff regarding prompt initiation of voluntary recalls to recover unsafe goods from the market. The document discusses about required preparations by firms with respect to distribution chain of distributors, and manufacturers’ procedure to initiate recalls; identification and prompt action; and to promptly communicate recall regarding information, press releases or any other public notices. | Link |
| Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs (Draft) | March 09, 2022 | The objective of this revised draft FDA guidance is to addresses and comply the requirement as amended by the Drug Supply Chain Security Act (DSCSA) of Federal Food, Drug, and Cosmetic Act (FD&C Act). | Link |
| Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions | March 11, 2022 | Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions | Link |
| (i) Human Gene Therapy Products Incorporating Human Genome Editing, and (ii) Human Gene Therapy Products Incorporating Human Genome Editing | March 15, 2022 | (i) Human Gene Therapy Products Incorporating Human Genome Editing, and (ii) Human Gene Therapy Products Incorporating Human Genome Editing | Link Link |
| Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4 Guidance for Industry | March 22, 2022 | The objective of this FDA guidance is to provide guidance to manufacturers with respect to compliance requirements as per 21 CFR part 4 applicable for ophthalmic drugs packaged with eye droppers, eye cups, or other dispensers. This guidance applies to approved products, pending applications, and products marketed under the section 505G of the FDA without an approved application under section 505 as per OTC monograph drugs). | Link |
| The FDA Office of Pharmaceutical Quality published a white paper on “Quality Management Maturity: Essential for Stable U.S. Supply Chains of Quality Pharmaceuticals” | April 05, 2022 | The white paper is published with the aim of having a maximally efficient, agile, flexible manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight. Manufacturers reach to the quality management maturity (QMM) state when they have reliable, consistent, and robust processes to run business that achieves quality objectives and also it promotes continual improvement. | Link Link |
| Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (Draft) | April 08, 2022 | The scope of this guidance is applicable to medical devices having software/ firmware/ programmable logic and software as a medical device. The guidance provides information regarding the cybersecurity that should be submitted while premarket submission of following types: De Novo requests, Premarket Notification (510(k)) submissions, Premarket Approval Applications (PMAs) and PMA supplements, Investigational Device Exemption (IDE) submissions, Product Development Protocols (PDPs) and Humanitarian Device Exemption (HDE) submissions. | Link |
| Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs | April 11, 2022 | The objective of the guidance is to provide requirements of submission of promotional materials for human prescription drugs to the FDA, produced by made by Applicant, Manufacturers, Distributors, Packers, or Entity acting on behalf of the applicant. The guideline also explains aspects e-Submission of promotional materials in eCTD. | Link |
| Classifying Approved New Drug Products and Drug-device Combination Products as Complex Products for Generic Drug Development Purposes | April 13, 2022 | The document provides details regarding examples and definitions of drug-device combination products, complex drugs The document also outlined responsibilities and process for the Office of Generic Drugs’ Complex Drug Working Group. | Link |
| Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry; Availability (Draft) | April 13, 2022 | The objective of this guideline is to recommend to sponsors who are in the process of developing medicinal formulations with the approach for evolving a Race and Ethnicity Diversity Plan to select representative Nos. of members from different populations in the US. This approach helps to ensure that the data gathered during the development work reflect the racial and ethnic diversity and helps to identify effects on efficacy or safety outcomes associated with, or occur commonly within these populations. | Link |
| Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use (Draft) | April 14, 2022 | The objective of this guidance is to identify the information that US FDA commonly asks while evaluating pH adjusters waiver request for generic drug products intended for ophthalmic, parenteral, or otic use. The guidance is applicable for the applicants of ANDA. | Link |
| Bioavailability Studies Submitted in NDAs or INDs – General Considerations | April 15, 2022 | The objective of this guideline is to recommend applicants and sponsors for submitting (BA) bioavailability information for INDs, NDAs, and NDA supplements. The requirement specified in this guidance is for dosage forms applicable for oral route of administration. It includes capsules, tablets, suspensions, solutions, IR, MR, ER, DR drug products. | Link |
| Drug Products, Including Biological Products, that Contain Nanomaterials – Guidance for Industry | April 21, 2022 | The objective of this guideline is provides guidance on the product development such as biological products having a nanomaterial in the finished dosage form. The objective on nanomaterials in drug product may be different depending on the functionality. It could be active ingredients, carriers loaded with an active ingredient or inactive ingredients. | link |
| FDA Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research issued guidance on “Providing Submissions in Electronic Format — Postmarketing Safety Reports” | April 27, 2022 | The objective of the guideline is to assist industry for regulatory submissions in electronic format to CDER and CBER. The document provides information regarding the electronic submission of postmarketing reports as per 21 CFR 314.98 and 314.80, 21 CFR 600.80, 21 CFR 310.305, 21 CFR part 4, subpart B – additional reports for combination products with approved BLAs, ANDAs or NDAs | Link |
| Electronic Submission of IND Safety Reports Technical Conformance Guide | April 29, 2022 | The objective of the guideline is to provide specifications, general considerations, and recommendations on how to submit electronic IND application safety reports to the CDER or CBER. This is the supplement guide to the draft guidance “Providing Regulatory Submissions in Electronic Format: IND Safety Reports dated October 2019”, as per requirements of section 745A(a) of the FD&C Act. | Link |
| FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products | April 29, 2022 | The objective of the guideline is to assist in electronic submission of individual case safety reports (ICSRs) and attachments to the CDER and CBER in the FDA. This guideline describes technical approach from FDA for submitting ICSRs, for adding its regionally controlled terminology, and for adding FDA FAERS regional data elements that are not given in the ICH E2B (R3) Implementation Guideline (IG) | Link |
| Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program (Draft) | May 06, 2022 | FDA has announced a 3rd party quality maturity appraisal and continuous improvement program. The intent of this program is to improve medical device quality and production. This is a voluntary program and does not mandate anyone to abide by the requirement. In this program participating manufacturer’s capability and performance will get reviewed with respect to key business processes. For more details, refer to the guidance. | Link |
| Benefit-Risk Considerations for Product Quality Assessments (Draft) | May 09, 2022 | The objective of this draft guideline is to provide information about benefit-risk principles applied by FDA when conducting product quality-related assessments of CMC information that have been submitted as part of original NDAs, BLAs in addition to other information available to FDA during its assessment. | Link |
| Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production – Level 2 revision | May 16, 2022 | FDA has revised the guidance on OOS applied to chemistry-based laboratory testing of drugs. The document provides FDA’s current thinking on how to evaluate OOS test results. | Link |
| Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 | May 17, 2022 | The objective of this guideline is to provide information regarding US FDA’s Generic Drug User Fee Amendments of 2017 also called as GDUFA II (Title III of the FDA Reauthorization Act of 2017) | Link |
| Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors | May 18, 2022 | The objective of this guidance is to support application holders, sponsors and applicants minimize medication errors regarding prescription drug and biological product applicable for humans. | Link |
| Risk Management Plans to Mitigate the Potential for Drug Shortages (Draft) | May 19, 2022 | The objective of this guidance is to implement a risk based plan in order to support the prevention of human drug product and biological product shortages. The plan will provide a framework to proactively identify, prioritize, and implement initiatives to prevent a supply disruption. | Link |
| Importation of Prescription Drugs Final Rule Questions and Answers; Small Entity Compliance Guide” | May 25, 2022 | The objective of the guideline is to help understand the rule, “Importation of Prescription Drugs,” that was published on 1-Oct-2020 (85 FR 62094). The purpose of the final rule was to get a good amount of reduction in the cost of covered products to the American consumer with no additional risk to the public’s health and safety. | Link |
| Electromagnetic Compatibility (EMC) of Medical Devices | June 6, 2022 | The objective of this document is to provide the guidance and recommendation on analysis to assess the electromagnetic compatibility of medical devices. Also the guideline provides information to include in the labeling. | Link |
| U.S. FDA announced pilot for lower radiation levels for device sterilization | June 7, 2022 | U.S. FDA is considering a master file pilot program for PMA (premarket approval) holders where approved devices are sterilized using radiation. The objective of this consideration is because of global supply chain constraints and to support sterilization supply chain resiliency. This program can help medical device manufacturers advance alternative ways to sterilize their approved medical devices. | Link Link |
| Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies (draft) | June 15, 2022 | The objective of this guideline is to provide a standards recognition program for regenerative medicine therapies (SRP-RMT) at CBER to identify and recognize VCS to help in developing and assisting RMT products regulated by CBER as appropriate. | Link |
| Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions | June 16, 2022 | FDA finalizes guidance on consideration for quantitative imaging algorithms in radiological device submissions. The guideline is required to be utilized along with existing devices and submission specific guidance documents. | Link |
| Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures (Draft) | June 21, 2022 | Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures | Link |
| Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination (Draft) | June 24, 2022 | The purpose of this guidance is to provide information of facility design elements, methods, and controls required to prevent product being cross-contaminated with compounds containing a beta-lactam ring. It covers probable health risk, and the potential for cross-reactivity in the classes of non-antibacterial beta-lactam compounds and non-penicillin beta-lactam antibacterial drugs. | Link |
| Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry | June 24, 2022 | The purpose of this guidance is to provide suggestions on an alternate electronic format required to be submitted under an exemption from or a waiver of the provisions of FD&C Act, section 745A(a). The scope of this guideline are NDAs, ANDAs, certain DMFs, BLAs, and INDs submitted to the CDER or CBER. | Link |
| Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations | June 24, 2022 | The purpose of this guidance is to provide suggestions to the applicants who are planning to perform food-effect (FE) studies for orally consumed drug products under INDs to support NDAs and supplements to these applications for drugs being developed under section 505 of the FD & C act. This document replaces and revises part of the 2002 FDA guidance entitled Food-Effect Bioavailability and Fed Bioequivalence Studies (December 2002). | Link |
| Nonprescription Drug Product With an Additional Condition for Nonprescription Use | June 28, 2022 | Nonprescription Drug Product With an Additional Condition for Nonprescription Use | Link |
| Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments (Draft) | June 29, 2022 | The objective of this guideline is to describe how patients, caregivers, researchers, medical product developers, and other stakeholders can compile and provide feedback about patient experience data and other applicable information from caregivers and patients to be used for regulatory decision-making and product development. | Link |
| Identifying Trading Partners Under the Drug Supply Chain Security Act (Draft) | July 5, 2022 | The FDA has issued the guideline to assist industry and stakeholders in understanding how to categorize the entities in the drug supply chain as per the DSCSA. | Link |
| DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry | July 6, 2022 | The purpose of this guideline is to identify the standards necessary to facilitate adoption of secure, interoperable, electronic data exchange among the pharmaceutical distribution supply chain, and clarifies the trading partners, products, and transactions subject to such standards. This guideline is applicable for manufacturers, dispensers, wholesale distributors, and repackagers who are engaged in transactions of “products” as defined in section 581(13) of the Food Drug & Cosmetic Act. | Link |
| Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format | July 15, 2022 | The purpose of this guideline is to provide suggestions for developing the information and format of a patient Instructions for Use (IFU) document for human prescription drug and drug-led or biologic-led combination products as well as biological products submitted under NDA or BLA. | Link |
| Human Prescription Drug and Biological Products–Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers-Dose Banding (Draft) | July 21, 2022 | The objective of this guideline is to support applicants to provide dose banding details into the drug labeling given in a NDA, BLA, or a supplement to these applications while the sponsor proposes to develop ready-to-use containers for different strengths and wants to add the dose banding details into the prescribing details of the proposed medicinal product that is depend on on dosing details of a already approved product which is based on weight or body surface area. | Link |
| Evaluation of Therapeutic Equivalence (Draft) | July 21, 2022 | The objective of this guideline is to explain the criteria that the US FDA uses to evaluate the therapeutic equivalence of drug products. It also consists of therapeutic equivalence (TE) codes. The details covered in these documents are related to the FDA evaluation criteria for drug products to determine TE for, multi-source drug products to be listed in the Approved Drug Products With Therapeutic Equivalence Evaluations publication (the Orange Book). | Link |
| Conducting Remote Regulatory Assessments Questions and Answers (Draft) | July 22, 2022 | The objective of this guideline is to explain FDA’s current thinking on use of remote regulatory assessments (RRAs) is to improve organizations’ understanding on RRAs and support FDA’s process to carry out RRAs. | Link |
| US FDA published guidance – Orange Book Questions and Answers Guidance for Industry | July 22, 2022 | The objective of this guideline is to provide guidance to interested organizations covering prospective drug product and drug product applicants as well as approved application holders for utilizing the Approved Drug Products With TE Evaluation publication (that is Orange Book). The document gives answers to generally asked questions that FDA have received regarding the Orange Book. | Link |
| Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry | July 22, 2022 | The objective of this guideline is to support ANDA applicants in responding to CRLs from FDA. The guideline gives recommendations and information related to required actions for an ANDA applicant on receipt of a CRL, and the actions that FDA may take when ANDA applicants fail to revert on CRL. | Link |
| Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices | July 25, 2022 | The objective of this guideline is to include US FDA’s compliance policy related to GUDID submission requirements for certain devices of class I category. | Link |
| General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry | July 27, 2022 | The objective of this guideline is to applicants of INDs, NDAs, BLAs, and supplements to these applications planning to carry out neonatal populations’ clinical studies. This document does not discuss the timing to start neonatal studies. This sponsor should discuss this topic with the relevant FDA review division. | Link |
| Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry (Draft) | August 02, 2022 | The purpose of this draft guideline is to assist ANDA applicants while submitting expedited safety reports of serious adverse events BA/BE studies in electronic form. Serious adverse events have been submitted to the Office of Generic Drug through telephone, email, or facsimile transmission as attachments. | Link |
| Charging for Investigational Drugs Under an IND: Questions and Answers (Draft) | August 23, 2022 | This guidance provide information to industry, physicians, researchers, institutional review boards (IRBs), and patients about the implementation of the FDA’s regulations on charging for investigational drugs under an investigational new drug application (IND) for either clinical trials or expanded access for treatment use (21 CFR 312.8), which went into effect on October 13, 2009. | Link |
| FDA issued Questions and Answers on “E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential” | August 26, 2022 | The purpose of the question-and-answer (Q&A) document is to clarify important issues for industry on Clinical Evaluation of the QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (October 2005) and Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals (October 2005). This advice updates ICH E14 Q&As Q12 (5.1) and Q13 (6.1), as well as adding new ICH S7B Q&As Q17 (1.1) to Q30 (4.2). This guidance is the final version of the draft guidance that was issued in September 2020. | Link |
| Q2(R2) Validation of Analytical Procedures | August 26, 2022 | This guideline discusses elements to be considered during the validation of analytical processes contained in registration applications submitted to ICH member regulatory authorities. Q2(R2) gives instructions and recommendations for developing and evaluating the numerous validation tests for each analytical technique. This guideline is a compilation of terminology and definitions. These words and meanings are intended to bridge the gaps that frequently exist between various compendia and papers produced by ICH member regulatory agencies. | Link |
| Q14 Analytical Procedure Development” on its website | August 26, 2022 | This guideline covers science-based and risk-based approaches to creating and maintaining analytical techniques appropriate for assessing the drug substances and drug products’ quality. The methodical approach proposed in ICH Q8 Pharmaceutical Development, together with the concepts of ICH Q9 QRM, can be applied to the development and management of analytical methods. A minimum (also known as conventional) approach or parts of an upgraded approach might be used while constructing an analytical technique. Furthermore, the guidance discusses factors to consider while developing multivariate analytical techniques and doing real-time release testing (RTRT). The objective of this guideline is to augment ICH Q2 Validation of Analytical Procedures. | Link |
| FDA published draft guidance on “Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products” | September 8, 2022 | Date of news: The guideline recommends the structure and content of the mandatory statement of identity on human nonprescription pharmaceutical product labeling. This document also includes recommendations for including the strength of the drug product on the labeling. The suggestions in this guidance are designed to assist manufacturers, packers, distributors, sponsors and applicants, in ensuring that the statement of identity and strength for all human nonprescription medication products is uniform in content and structure. Consistent content and structure of the declaration of identity and strength may help consumers compare nonprescription medicine goods and make appropriate self-selection decisions. Source: | Link |
| Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products (Draft) | September 8, 2022 | This document contains guidelines for quantitative labeling of salt, potassium, and phosphorus in human prescription and over-the-counter (OTC) medications. | Link |
| Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products | September 9, 2022 | This recommendation encourages sponsors and applicants to indicate specific usage of RWD/RWE in their submission cover letters in order to facilitate FDA’s internal monitoring of submissions to the Agency that incorporate RWD/RWE. | Link |
| Computer Software Assurance for Production and Quality System Software (Draft) | September 13, 2022 | This proposed guidance is meant to: Give an explanation of “computer software assurance” as a risk-based strategy to develop trust in the automation employed in production or quality systems and indicate any areas where more rigor may be necessary; and Describe several techniques and testing procedures that could be used to establish computer software assurance and offer unbiased proof to satisfy legal requirements, such as the computer software validation standards in 21 CFR part 820. (Part 820). | Link |
| Q3D(R2) – Guideline for Elemental Impurities | September 14, 2022 | Elemental impurities in drug products can come from a variety of sources. For example, they can be leftover catalysts that were purposefully added during synthesis, or they can be present as impurities due to interactions with processing machinery, container/closure systems, or components of the drug product. | Link |
| How To Obtain a Covered Product Authorization | September 21, 2022 | According to the website, this draft document will replace the December 2014 draft guidance for industry How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD. The draft guidance published in December 2014 guidance has been withdrawn. | Link |
| Electronic Submission Template for Medical Device 510(k) Submissions | September 22, 2022 | This guideline outlines additional requirements for premarket notice (510(k)) submissions made in an electronic format, a timeline for their formation, and the standards that must be reached in order to be exempted or waived from a statutory requirement. | Link |
| Ethical Considerations for Clinical Investigations of Medical Products Involving Children (Draft) | September 23, 2022 | The FDA’s current position on ethical issues for pediatric clinical trials of medicinal goods is described in this document. For information on the safety and efficacy of medications, biological products, and medical devices in children as well as to safeguard children from the dangers associated with exposure to potentially harmful or ineffective medical goods, clinical investigations in children are crucial. | Link |
| Ethical Considerations for Clinical Investigations of Medical Products Involving Children (Draft) | September 26, 2022 | Clinical studies in children are critical for gaining data on the safety and effectiveness of medications, biological products, and medical devices in children, as well as protecting children from the dangers associated with exposure to potentially hazardous or ineffective medical goods. | Link |
| Providing Over-the-Counter Monograph Submissions in Electronic Format (Draft) | September 27, 2022 | The Food and Drug Administration (FDA or Agency) has made a draft advice for industry titled “Providing Over-the-Counter Monograph Submissions in Electronic Format” available. This advice explains how to submit electronic submissions to the FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act). | Link |
| Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions | September 28, 2022 | The FDA’s guidelines on clinical performance assessments to support premarket notification (510(k)) submissions for computer-assisted detection (CADe) devices applied to radiography pictures and radiology device data are provided in this guidance paper. This recommendation applies to CADe devices, including the detection aspect of combined computer-aided detection and diagnostic equipment. The guidelines are meant to increase uniformity and speed up the consideration of clinical performance assessments in CADe 510(k) applications. | Link |
| Clinical Decision Support Software | September 28, 2022 | The final advice underscores that the FDA’s existing digital health standards continue to apply to software functionalities that fit the definition of a device, including those used by patients or caregivers. The final guidance also includes examples of how the FDA implements the Non-Device CDS criterion. These examples distinguish between Non-Device CDS functions that satisfy all four requirements and device functions that do not satisfy one or more of the criteria. | Link |
| Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Notification [510(k)] Submissions | September 28, 2022 | This document contains the FDA’s guidelines for premarket notification (510(k)) submissions for computer-assisted detection (CADe) devices used on radiological pictures and radiography device data. This advise applies to all CADe devices, including those sold as a full package with a review workstation, as add-on software incorporated into imaging equipment, as an image review platform, or as other imaging accessory equipment. The guidelines are designed to encourage uniformity and make 510(k) submissions for CADe devices more efficient. | Link |
| Display Devices for Diagnostic Radiology | September 28, 2022 | This paper contains the FDA’s recommendations for premarket notification (510(k)) submissions for display devices used in diagnostic radiology. This advise relates to diagnostic radiological display devices as defined by their categorization rule (21 CFR 892.2050) and product numbers. This covers diagnostic radiological display equipment such as soft-copy displays and medical grade monitors. The suggestions are meant to encourage uniformity and make it easier to examine display devices. | Link |
| Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices | September 28, 2022 | Following the issue of the final rule, “Medical Devices; Medical Device Classification Regulations to Conform to Medical Software Provisions in the 21st Century Cures Act,” this guideline was altered through a minor modification to reflect amended medical device classification regulations (86 FR 20278). | Link |
| Policy for Device Software Functions and Mobile Medical Applications | September 28, 2022 | This guideline was changed with a minor modification to accommodate amended medical device categorization requirements as a result of the final rule, “abcMedical Devices; Medical Device Classification Regulations To Conform to Medical Software Provisions in the 21st Century Cures Act” (86 FR 20278), as well as to update information impacted by the final guidance, “Clinical Decision Support Software.” | Link |
| FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals | October 3, 2022 | The Federal Food, Drug, and Cosmetic Act (the FD&C Act) was amended by the Medical Device User Fee Amendments of 2022 (MDUFA V), allowing FDA to charge user fees for the review of specific premarket submissions received on or after October 1, 2022, such as premarket notification submissions (510(k)s). | Link |
| Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA | October 3, 2022 | Owners of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that will be cited in an abbreviated new drug application (ANDA) or a prior approval supplement to an ANDA are the target audience for this guidance. The “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023–2027” document outlines how FDA would implement a programme improvement that was agreed upon by the Agency and industry as part of discussions to reauthorize the Generic Drug User Fee Amendments (GDUFA) (GDUFA III commitment letter). | Link |
| Facility Readiness: Goal Date Decisions Under GDUFA (Draft) | October 3, 2022 | In accordance with section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)), this guideline explains how FDA intends to set a goal date based on a facility’s readiness for inspection as certified on Form FDA 356h, submitted as a part of an original abbreviated new drug application (ANDA). | Link |
| Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules | October 3, 2022 | In comparison to other dosage forms, tablets and capsules are often produced, prescribed, and may offer a variety of benefits such as the convenience of storage, portability, ease of administration, and accuracy in dosing. This guideline explains the requirement for Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules. | Link |
| Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments | October 5, 2022 | In accordance with the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023–2027, this guidance describes how FDA will issue and use an information request (IR) and/or a discipline review letter (DRL) during the evaluation of an initial abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (GDUFA III commitment letter). A supplement or a modification to a supplement are not covered by this advice. | Link |
| Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA Guidance for Industry | October 5, 2022 | The Federal Food, Drug, and Cosmetic Act’s section 505(j) (21 U.S.C. 355(j)) allows for the submission of abbreviated new drug applications (ANDAs), and this guidance offers recommendations to the industry on post-complete response letter (CRL) teleconferences (post-CRL clarification teleconferences) between the FDA and ANDA applicants for the purpose of clarifying deficiencies identified in a CRL to an ANDA. This guidance’s processes are meant to assist ensure that post-CRL clarification teleconferences are well-managed and that they are planned and held within the time constraints specified in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023–2027. (GDUFA III commitment letter). | Link |
| Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry | October 5, 2022 | This guideline defines an expanded pathway for talks between FDA and a prospective applicant who is planning to submit an abbreviated new drug application (ANDA) to FDA or an applicant who has already filed an ANDA for a complicated product under this guidance. This advice offers details on requesting and holding meetings with FDA for product development, pre-submission, mid-cycle review, enhanced mid-cycle review, and post-complete response letter scientific meetings. | Link |
| Competitive Generic Therapies | October 5, 2022 | The FDA Reauthorization Act of 2017, or FDARA, established a procedure whereby the FDA may designate a medicine with “inadequate generic competition” as a competitive generic treatment upon the applicant’s request (CGT). A CGT medication’s abbreviated new drug application (ANDA) development and review may also be sped up by FDA at the applicant’s request. | Link |
| Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA | October 13, 2022 | The purpose of this final guidance is to assist original applicants and holders of approved NDAs, ANDAs, and BLAs in implementing chemistry, manufacturing, and controls (CMC) postapproval change using a comparability protocol (CP). | Link |
| ANDA Submissions – Prior Approval Supplements Under GDUFA” | October 14, 2022 | This guidance is intended to help applicants who are prepared to submit to FDA prior approval supplements (PASs) and changes to PASs for ANDAs under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)). | Link |
| Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care (Draft) | October 21, 2022 | This guidance proposes specific updates to the guidance that clarify how the programme may apply to certain medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions in populations impacted by health and/or health care disparities. The current Breakthrough Devices Program guidelines will continue in force until this draught guidance is approved. | Link |
| Human Gene Therapy for Neurodegenerative Diseases | October 21, 2022 | This advice gives recommendations to sponsors developing human gene therapy (GT) products for adult and paediatric patients suffering from neurodegenerative disorders. Neurodegenerative diseases are a diverse set of conditions defined by gradual deterioration of the central nervous system or peripheral nervous system structure and function. The genesis, frequency, diagnosis, and therapy of these diseases vary, and they include both hereditary and age-related disorders. This document focuses on product development, preclinical testing, and clinical trial design. | Link |
| Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs | October 21, 2022 | This guideline is designed to help applicants who are submitting abbreviated new drug applications (ANDAs) for liquid-based and/or other semisolid products applied to the skin, 18 including integumentary and mucosal (e.g., vaginal) membranes, referred to as 19 topical products. Topical 21 goods (other than topical solutions) are categorised as complex products due to the complicated mode of administration associated with these products, 20 which are often locally active, and the possible complexity of some formulations. | Link |
| In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs | October 21, 2022 | The purpose of this advice is to assist applicants who are submitting abbreviated new drug applications (ANDAs) for liquid-based and/or other semisolid products applied to the skin, including integumentary and mucosal (e.g., vaginal) membranes, which are referred to as topical products. Topical treatments (other than topical solutions) are categorised as complex products due to the complicated route of administration associated with these products, which are often locally active, and the possible complexity of some formulations. This document contains suggestions for in vitro release test (IVRT) studies that may be used to compare a proposed generic (test) topical product to its reference standard (RS) in order to support a demonstration of bioequivalence (BE) to the reference listed medicine (RLD). The RLD is typically used as the reference standard. | Link |
| In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs (Draft) | October 21, 2022 | This guideline is designed to help applicants who are submitting abbreviated new drug applications (ANDAs) for liquid-based and/or other semisolid products applied to the skin, including integumentary and mucosal (e.g., vaginal) membranes, which are referred to as “topical products” in this document. Topical treatments (other than topical solutions) are categorised as complex products due to the complicated route of administration associated with these products, which are often locally active, and the possible complexity of some formulations. This document contains recommendations for in vitro permeation test (IVPT) studies that compare a proposed generic (test) topical product to its reference standard (RS) in order to provide a demonstration of bioequivalence (BE) to the reference listed drug (RLD). The RLD is typically used as the reference standard. | Link |
| Multiple Endpoints in Clinical Trials Guidance for Industry | October 21, 2022 | This guidance provides sponsors and review staff with the Agency’s thinking on the problems posed by multiple endpoints in the analysis and interpretation of study results, as well as how to manage these problems in clinical trials for human drugs, including drugs subject to licencing as biological products. Most clinical trials in drug development have numerous endpoints to assess the treatment’s effects and demonstrate the drug’s capacity to improve one or more disease features. | Link |
| Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions | October 26, 2022 | The purpose of this guidance document is to assist Food and Drug Administration (FDA) staff in formulating a request for further information in compliance with the Least Burdensome Provisions of the FD&C Act in order to reach a judgement regarding a medical device marketing application. A “deficiency” is the term for such an FDA request for additional information. In order to make the best use of both industry and FDA’s time, this advice also offers suggested formats for FDA personnel to utilise when communicating shortcomings and for industry to use when responding to such requests. | Link |
| Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention (Draft) | October 27, 2022 | The Food and Drug Administration has made a proposed guidance for industry titled “Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention” availabl. The goal of this proposed guideline is to aid sponsors in the clinical development of medications for the treatment, reduction of recurrence, or prevention of Clostridioides difficile infection (CDI). | Link |
| Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials; Draft Guidance for Industry; Availability (Draft) | October 31, 2022 | This guidance is designed to help sponsors track growth and, where necessary, pubertal development in paediatric study participants with both uncommon and common disorders. This guideline offers suggestions for the best ways to gauge pubertal development and measure and record growth in order to assess safety. | Link |
| Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) – Small Entity Compliance Guide | November 1, 2022 | This guideline was created by the FDA in compliance with Section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). It aims to aid small entity businesses that produce human cells, tissues, or cellular or tissue-based products (HCT/Ps) in understanding the thorough regulatory framework for HCT/Ps that is outlined in Title 21 of the Code of Federal Regulations, part 1271. (21 CFR 1271). Important terminology used in 21 CFR 1271 are defined in section 21 CFR 1271.3. | Link |
| Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers (Draft) | November 1, 2022 | In order to comply with FDA regulations on expanded access to investigational drugs for treatment use under an investigational new drug application (IND) (21 CFR part 312, subpart I), which took effect on October 13, 2009, this guidance provides information for business, researchers, physicians, institutional review boards (IRBs), and patients. Regarding the execution of the legal requirements for wider access, FDA got a lot of inquiries. | Link |
| Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program (Draft) | November 1, 2022 | In accordance with sections 744L and 744M of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), which were added by the Coronavirus Aid, Relief, and Economic Security Act (or the CARES Act), the Food and Drug Administration (FDA) is authorised to charge and collect user fees from qualified manufacturers of OTC monograph drugs and requestors of OTC monograph order requests, other than OMORs | Link |
| S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals | November 2, 2022 | All medications that must undergo carcinogenicity testing in accordance with ICH S1A are covered by this Addendum. Refer to the ICH industry guidance S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (May 2012) for information on pharmaceuticals derived from biotechnology. | Link |
| Cross Labeling Oncology Drugs in Combination Regimens Guidance for Industry | November 2, 2022 | Oncology medication approvals frequently enhance the therapeutic effectiveness of existing regimens by include new pharmaceuticals or by merging experimental medicinal products to form a combination regimen, resulting in new regimens with higher efficacy. Historically, applicants have not asked for modifications to a drug’s labelling to explain how to take it in a different regimen (cross labeling). | Link |
| Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial | November 4, 2022 | This guideline is intended to offer suggestions to sponsors looking to test several iterations of a cellular or gene therapy product in an early-phase clinical trial for a particular condition. In a single clinical study, sponsors have indicated interest in obtaining preliminary proof of the efficacy and safety of several iterations of a cellular or gene therapy product. | Link |
| Sameness Evaluations in an ANDA – Active Ingredients (Draft) | November 8, 2022 | The guidance is intended to assist applicants preparing an abbreviated new drug application (ANDA) by providing recommendations on demonstrating similarity between the active ingredient in a proposed generic drug product and its reference listed drug (RLD), as required by section 505(j)(2)(A)(ii) of the FD&C Act and FDA regulations of § 314.94(a)(5) (21 CFR 314.94(a)(5)) | Link |
| Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents | November 14, 2022 | This guideline is being issued by FDA to clarify our approach to referring to the terms “device” and “counterfeit device” in FDA publications. For many years, the concept of “device” has been established in FD&C Act section 201(h). The definition of device was renamed to section 201(h)(1) of the FD&C Act upon the passage of the Safeguarding Therapeutics Act in January 2021, and the new term “counterfeit device” and its meaning were designated at section 201(h)(2) of the FD&C Act. | Link |
| Cybersecurity Modernization Action Plan | November 17, 2022 | A new action plan for tackling cybersecurity has been announced by the US Food and Drug Administration (FDA), stating the agency’s aim to improve, modernise, and upgrade its defences against assets and data. | Link |
| Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food Drug and Cosmetic Act | November 18, 2022 | Regarding the production of beta-lactam oral antibiotic suspension products that are included on the FDA’s medication shortage list by a licensed pharmacist in a State-licensed pharmacy or Federal facility, this guideline outlines the FDA’s regulatory and enforcement priorities. There is a severe lack of amoxicillin oral antibiotic powder for suspension right now. Products made of the oral antibiotic amoxicillin powder for suspension are now listed as being in low supply by the FDA. | Link |
| Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies | November 28, 2022 | The FDA examined information from stakeholders, including doctors, scientists, and patients concerned about adequate access to FMT for patients with C. difficile infection who are not responding to traditional therapy, in developing this policy. The FDA created this strategy to enable patients gain access while also addressing and managing the dangers that centralised manufacture in stool banks poses to persons receiving such goods. | Link |
| Questions and Answers Regarding Food Allergen Labeling (Edition 5) (Draft) | November 29, 2022 | The FDA is releasing Edition 5 (Final Guidance) to replace Edition 4 (Final Guidance), which was issued in 2006. With the exception of minor or editorial modifications, Edition 5 (Final Guidance) retains the questions and answers from Edition 4 (Final Guidance). Furthermore, the FDA is providing this advice, Edition 5 (Draft Guidance), to solicit feedback on the additional or updated questions and answers. It should be noted that some questions and answers from Edition 4 (Final Guidance) have been withdrawn and moved to this Edition 5 (Draft Guidance) for feedback if the FDA concluded that the question and answer needed to be altered in any way. | Link |
| A senior FDA official advocates for cloud-based regulatory reviews | November 30, 2022 | At a symposium on drug master files (DMFs) and structured data submissions on November 30, a top US Food and Drug Administration (FDA) official touted the benefits of cloud-based regulatory submissions in ensuring consistent product reviews and explained how the agency is moving toward this platform through ongoing internal and international harmonisation initiatives. | Link |
| Statistical Approaches to Establishing Bioequivalence (Draft) | December 2, 2022 | Part 320 specifies the requirements for submitting bioavailability (BA) and bioequivalence (BE) data in investigational new drugs (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements, as well as the definitions of BA and BE and the types of in vitro and in vivo studies appropriate for measuring BA and establishing BE (21 CFR part 320). This advice includes recommendations for meeting Part 320 requirements for all drug products. | Link |
| ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions (Draft) | December 2, 2022 | The Food and Drug Administration (FDA) is issuing this revised draught guidance to incorporate programme enhancements related to the content, timing, and assessment of a pre-submission facility correspondence (PFC) within the abbreviated new drug application (ANDA) assessment program3 agreed upon by the Agency and industry as part of the Generic Drug User Fee Amendments (GDUFA III) reauthorization, as described in GDUFA Reauthorization Performance Goals and Program E. | Link |
| Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer | December 06, 2022 | This document provides recommendations for sponsors of investigational new drug (IND) and biologics licence application (BLA) submissions under 42 U.S.C. 262 and 21 CFR Parts 312 and 601 on the use of pharmacokinetic (PK)-based criteria to support the approval of alternative dosing regimens for programmed cell death receptor-1 (PD-1) or programmed cell death-ligand 1 (PD-L1) blocking antibodies. | Link |
| Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations (Draft) | December 06, 2022 | Aluminum toxicity in parenteral nutrition (PN) is a serious safety problem, demanding that PN products fulfil the standards for aluminium content and labelling in 21 CFR 201.323. Aluminum concentration in large volume parenteral (LVP) medication products used in total parenteral nutrition (TPN) therapy shall not exceed 25 micrograms per litre (mcg/L), according to the law. The aluminium content restrictions of small volume parenteral (SVP) medication products and pharmacy bulk packages (PBPs) used in PN, on the other hand, are not set by legislation or regulation. Furthermore, the International Council for Harmonisation (ICH) has not defined a PDE for aluminium. | Link |
| Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry | December 07, 2022 | This guideline explains how we plan to prioritise enforcement and regulatory actions for homoeopathic medicine products marketed in the United States without FDA clearance. As explained further below, the FDA has devised a risk-based strategy through which the Agency plans to prioritise enforcement and regulatory actions concerning certain categories of such goods that may represent a larger risk to public health. | Link |
| Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers (Draft) | December 09, 2022 | The FDA is issuing this draught guidance to assist manufacturers in better understanding and implementing the Voluntary Summary Malfunction Reporting (VMSR) Program, which is an established voluntary programme in which manufacturers may submit certain malfunctions related to devices with specific product codes to the FDA in a summary format on a quarterly basis. The FDA’s VMSR Program is intended to benefit both the FDA and the public by increasing transparency for the public, assisting the FDA in processing certain malfunction reports efficiently, allowing both the FDA and the public to more easily identify malfunction trends, and reducing the burden on manufacturers. The purpose of this advisory is to explain, rather than modify, the terms of the VMSR Program. | Link |
| Content of Human Factors Information in Medical Device Marketing Submissions | December 09, 2022 | This draft guideline paper contains the FDA’s recommendations for human factors information that should be captured and included in medical device marketing submissions where such submissions are necessary. The guidelines are meant to increase uniformity and speed up the examination of medical device applications. | Link |
| Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry” | December 14, 2022 | This guideline is designed to help applicants of ANDAs submitted under section 505(j) of the Federal FD&C Act (21 U.S.C. 355(j)) reply to FDA complete response letters (CRLs). ANDA applicants are obligated by rule to take action after obtaining a CRL. The guideline updates the guidance given in July 2022 with the same title. The purpose of this change is to include the performance objectives established in the Generic Drug User Fee Amendments. Performance Goals and Program Enhancements for Fiscal Years 2023-2027. | Link |
| Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection (December 2022) (Draft) | December 15, 2022 | A draft of a guideline document titled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection” is now available, according to the Food and Drug Administration (FDA or Agency). The Federal Food, Drug, and Cosmetic Act (FD&C Act) was amended by the FDA Reauthorization Act of 2017 (FDARA), and as a result, a device is now considered adulterated if the owner, manager, or agent of the factory, warehouse, or establishment where it is made, processed, packed, or stored delays, refuses, or restricts an FDA inspection. | Link |
| Controlled Correspondence Related to Generic Drug Development (Draft) | December 21, 2022 | This guidance explains how generic medication makers and allied industries, or their representatives, can submit restricted communication to the FDA seeking generic drug development information. This guideline also covers the Agency’s procedure for communicating with recipients of such mail. | Link |