The Commissioner, following revocation of a biologics license under 21 CFR 601.5(b) , will publish a notice in the Federal Register with a statement of the specific grounds for the revocation.
21 CFR Part 601 · Licensing
§ 601.8 Publication of revocation
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.
Amendment history
Federal Register documents that created or amended this section.
- 74 FR 20585 5 May 2009