Pharma GMP News of the Week: 30-January-2022

Period: January 23, 2022 to January 29, 2022

FDA has published revised draft guidance on “Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry”

Date of issue: January 25, 2022

The purpose of the guideline is

(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.

Source: https://www.fda.gov/media/155661/download

FDA has published guidance on “Patient Engagement in the Design and Conduct of Medical Device Clinical Studies”

Date of issue: January 26, 2022

As per the FDA, this purpose of this guidance is

(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

Source: https://www.fda.gov/media/130917/download

FDA has published guidance on “Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation”

Date of issue: January 26, 2022

The intent of this guidance is:

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.

Source: https://www.fda.gov/media/141565/download

FDA has published guidance on “Principles of Premarket Pathways for Combination Products”

Date of issue: January 26, 2022

This guidance provides outline about:

(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.

Source: https://www.fda.gov/media/119958/download

FDA has published guidance on “Information Requests and Discipline Review Letters Under GDUFA”

Date of issue: January 26, 2022

The purpose of this guideline is to:

(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.

Source: https://www.fda.gov/media/109915/download

FDA has published guidance on “Good ANDA Submission Practices”

Date of issue: January 26, 2022

The intent of this guideline is to:

(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.

Source:  https://www.fda.gov/media/110689/download

Major change in Clinical Trials Regulation in the EU: Harmonistion of the assessment and supervision processes throughout the European Union as per Clinical Trials Information System (CTIS)

In EU region, clinical trials undergo a major change as soon as Clinical Trials Regulation (Regulation (EU) No 536/2014) comes into effect on January 31, 2022. There will be a hamonisation in assessment and supervision processes through Clinical Trials Information System (CTIS) in entire EU. There will be a centralized portal and database for this purpose in EU.

Source:

(i) https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-regulation

(ii) https://www.ema.europa.eu/en/news/regulatory-harmonisation-clinical-trials-eu-clinical-trials-regulation-enter-application-new

The ICH published Training Material on E9(R1) its website

On 28 January 28, 2022 ICH announced the availability of training material on ICH E9(R1) “Addendum on estimands and sensitivity analysis in Clinical trials to the guideline on statistical principles for clinical trials”

Date of news: January 28, 2022

Source: https://database.ich.org/sites/default/files/E9%28R1%29%20Training%20Material%20-%20PDF_0.pdf

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