> ## Content Index
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# New CDER Web Page Housing EUA Docs/Requirements
- URL: https://www.fdaweb.com/new-cder-web-page-housing-eua-docs-requirements/
- Published: 2021-03-18T12:00:00.000Z
- Updated: 2026-09-14T16:51:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148910

CDER has created a new [Web page](https://www.fda.gov/drugs/coronavirus-covid-19-drugs/cder-scientific-review-documents-supporting-emergency-use-authorizations-drug-and-biological?utm%5Fmedium=email&utm%5Fsource=govdelivery) to house scientific review documents supporting emergency use authorizations (EUAs) for drug and biological therapeutic products, including any amendments. The Center says that the page is intended to “promote public confidence in FDA’s scientific review process” and it is “consistent with our longstanding practice of posting scientific reviews after new drug and biological product approvals.” The most recent postings include: 

- A requirement for Eli Lilly on the [monitoring and assessment of emerging global viral variants](https://www.fda.gov/media/146272/download?ref=fdaweb.com) involving its EUA for bamlanivimab.
- A [similar requirement](https://www.fda.gov/media/146274/download?ref=fdaweb.com) on Lilly’s EUA for bamlanivimab and etesevimab.
- A [similar requirement](https://webmail.emailsrvr.com/a/webmail.php?wsid=d9caa8725ab041408a98d28ebccedd86-453455c5ec9e4498941291fb1fa1d0e3&ref=fdaweb.com) on Regeneron Pharmaceuticals’ EUA for casirivimab (REGN10933) and imdevimab.

Each requirement contains language requiring the manufacturer to “establish a process for monitoring genomic database(s) for the emergence of global viral variants of SARS-CoV-2.” It also asks for a summary of the process to be submitted to the agency as soon as practicable. And, it requires each manufacturer to “provide reports to the agency on a monthly basis summarizing any findings as a result of its monitoring activities and, as needed, any follow-up assessments planned or conducted.”