FDA Revises Q&A Guidance on Pandemic-Era Generic Drug Development

The FDA has revised its guidance on generic drug development and application submission during the COVID-19 public health emergency, providing additional information and clarification of existing policies but no policy changes.

First published in April of this year, Development of Abbreviated New Drug Applications (ANDAs) During the COVID-19 Pandemic — Questions and Answers is a compilation of questions from industry and answers from FDA about generic drug product development and application assessment during the pandemic. Topics also include marketing and exclusivity.

The revised guidance includes more information for ANDA applicants on when the FDA will receive an ANDA with less than the full complement of recommended stability data and additional information on approaches for when a test product batch used in the conduct of a bioequivalence study expires while the study is interrupted.

The guidance clarifies that the FDA will generally accept requests to receive an ANDA without all the recommended stability data if the drug product is on the FDA’s Drug Shortage List or the FDA confirms that the drug product is vulnerable to shortage.