GroundRules
21 CFR 312.85: Phase 4 studies.
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 312—INVESTIGATIONAL NEW DRUG APPLICATION
- Subpart E—Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses
Concurrent with marketing approval, FDA may seek agreement from the sponsor to conduct certain postmarketing (phase 4) studies to delineate additional information about the drug's risks, benefits, and optimal use. These studies could include, but would not be limited to, studying different doses or schedules of administration than were used in phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time.
Collected 2026-08-27T02:24:47Z. Source file · JSON