Pharma GMP News of the Week: 24-July-2022
Period: July 17, 2022 to July 23, 2022
US FDA published draft guidance – Human Prescription Drug and Biological Products–Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers–“Dose Banding”
Date of news: 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.
Source: https://www.fda.gov/media/160036/download
US FDA published draft guidance – Evaluation of Therapeutic Equivalence
Date of news: 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).
Source: https://www.fda.gov/media/160054/download
US FDA published draft guidance – Conducting Remote Regulatory Assessments Questions and Answers
Date of news: 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.
Source: https://www.fda.gov/media/160173/download
US FDA published guidance – Orange Book Questions and Answers Guidance for Industry
Date of news: 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.
Source: https://www.fda.gov/media/160167/download
US FDA published guidance – Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry
Date of news: 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.
Source: https://www.fda.gov/media/160166/download
News from EMA “Global regulators call for international collaboration to integrate real-world evidence into regulatory decision-making”
Date of news: July 22, 2022
To read an article published on the EMA website, click on the following link.