21 CFR 314.500 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 370-499) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 370-499) — Drugs For Human Use (Subpart A To Parts 370-499) — Applications For Fda Approval To Market A New Drug (§ 314.1 To § 314.650) — Accelerated Approval Of New Drugs For Serious Or Life-Threatening Illnesses (§ 314.500 To § 314.560) — Scope.

4 Aug 2016

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 314.500
[57 FR 58958, Dec. 11, 1992, as amended at 64 FR 402, Jan. 5, 1999]