21 CFR § 314.500 Applications for FDA Approval to Market a New Drug

§ 314.500 Scope.

Current through Sep 8, 2026 · Read all of Part 314

⚠ 4 pending changes to Part 314

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).

[57 FR 58958, Dec. 11, 1992, as amended at 64 FR 402, Jan. 5, 1999]

← § 314.445 Guidance documents.§ 314.510 Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity. →