This subpart applies to certain new drug 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 314 · Applications for FDA Approval to Market a New Drug
§ 314.500 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 § 314.500
- Development of Non-Opioid Analgesics for Acute Pain draft 13 May 2026
- Development of Non-Opioid Analgesics for Chronic Pain draft 13 May 2026
- Accelerated Approval – Expedited Program for Serious Conditions draft 5 Dec 2024
- Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics draft 24 Mar 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
- Expedited Programs for Serious Conditions | Drugs and Biologics 30 May 2014
- Clinical Considerations for Therapeutic Cancer Vaccines: Guidance for Industry 1 Oct 2011
Amendment history
Federal Register documents that created or amended this section.
- 57 FR 58958 11 Dec 1992
- 64 FR 402 5 Jan 1999