21 C.F.R. § 314.500 Scope.
Title 21 - Food and Drugs
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]
Title 21: Food and Drugs
PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
Subpart H—Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses
§ 314.500 Scope.
