Public Comment on FDA COVID-19-Related Guidance Documents

In the 3/25/2020 issue of the Federal Register, the U.S. Food and Drug Administration (FDA) announced its process for making COVID-19-related Guidance Documents available for public comment.  FDA is issuing Guidance Documents for immediate implementation without prior public comment, but FDA will solicit post-issue comments.  FDA will periodically release consolidated “Notices of Availability” (NOA) for public comments, and comments are to be submitted to specific docket numbers (assigned to specific FDA Centers/Offices).  FDA published its first consolidated NOA, concerning 16 COVID-19-related Guidance Documents, in the 5/12/2020 issue of the Federal Register.  Based on public comments and evolving COVID-19 developments, FDA will revise Guidance Documents.  Beyond publication in the Federal Register, FDA Guidance Documents are available on the FDA website.