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# FDA Revises Covid ANDA Q&A Guidance
- URL: https://www.fdaweb.com/fda-revises-covid-anda-q-a-guidance/
- Published: 2021-09-08T12:00:00.000Z
- Updated: 2026-09-14T17:13:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150096

FDA has revised a guidance, *Development of Abbreviated New Drug Applications During the Covid-19 Pandemic—Questions and Answers*, which collects questions the agency has received from prospective applicants and applicants of ANDAs about generic drug product development and application assessment during the Covid-19 public health emergency. The 4/2021 [document](https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders?utm%5Fmedium=email&utm%5Fsource=govdelivery) provides general recommendations in the form of questions and answers in topic categories including generic drug product development, ANDA submission and assessment, and marketing and exclusivity. The revisions include: 

- clarification on when FDA will accept requests to receive an ANDA with less than the full complement of recommended stability data;
- additional information on approaches for when a test product batch used in an interrupted bioequivalence study expires; and
- other minor updates to the frequently asked questions.