Biological products approved under this subpart are subject to the postmarketing recordkeeping and safety reporting applicable to all approved biological products.
21 CFR Part 601 · Licensing
§ 601.93 Postmarketing safety reporting
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
FDA guidance that cites § 601.93
- Product Development Under the Animal Rule 2 Oct 2015
Amendment history
Federal Register documents that created or amended this section.
- 38 FR 32052 20 Nov 1973