Issued by:

Guidance Issuing Office

Center for Biologics Evaluation and Research

Center for Drug Evaluation and Research

FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.

FDA is issuing this guidance to provide information pertaining to review timelines that FDA will use during the COVID-19 public health emergency for the following applicant responses to complete response (CR) letters when a facility assessment is necessary before FDA can take action on a marketing application:

  • Amendments to original and supplemental abbreviated new drug applications (ANDAs) submitted to FDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
  • Resubmissions of original and supplemental biologics license applications (BLAs) submitted to FDA under sections 351(a) and (k) of the Public Health Service (PHS) Act. 2

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.