GroundRules
21 CFR 314.500: Scope.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER D—DRUGS FOR HUMAN USE
- PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
- Subpart H—Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses
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).
Collected 2026-08-27T02:24:47Z. Source file · JSON