GroundRules
21 CFR 601.40: 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 F—BIOLOGICS
- PART 601—LICENSING
- Subpart E—Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses
This subpart applies to certain biological 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