This subpart applies to certain biological products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments (e.g., ability to treat patients unresponsive to, or intolerant of, available therapy, or improved patient response over available therapy).
21 CFR Part 601 · Licensing
§ 601.40 Scope
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 § 601.40
- Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry 19 Oct 2023
- Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment draft 4 Dec 2018
- Special Protocol Assessment Guidance for Industry 16 Apr 2018
- Product Development Under the Animal Rule 2 Oct 2015
- Systemic Lupus Erythematosus --Developing Medical Products for Treatment 22 Jun 2010
- Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines: Guidance for Industry 31 May 2007
Amendment history
Federal Register documents that created or amended this section.
- 38 FR 32052 20 Nov 1973