C.F.R. » Title 21 » 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

21 C.F.R. § 312.85

Phase 4 studies

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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.

Notes of Decisions
Cited in 3 cases, 2007–2011 · leading case: Graves v. Sec'y of Dept. of Health & Human Servs., 101 Fed. Cl. 310 (Fed. Cl. 2011).
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Graves v. Sec'y of Dept. of Health & Human Servs., 101 Fed. Cl. 310 (Fed. Cl. 2011). “" 21 C.F.R. 312.85(2004). . Again, this "control” vaccine caused seizures, lending to the increased concern about Prevnar which had twice as many seizures.”
Abigail All. for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007). “so that each panel shall consist of— (A)members who are qualified by training and experience to evaluate the safety and effectiveness of the drugs to be referred to the panel and who, to the extent feasible, possess skill and experience in the development, manufacture, or…”
Abigail All. for Better Access v. Von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007). “" 21 C.F.R. § 312.85 . [3] Section 355(n)(3) of Title 21, United States Code, provides: The Secretary shall make appointments to each panel .”
— 21 C.F.R. § 312.85(2004) — 1 case
Graves v. Sec'y of Dept. of Health & Human Servs., 101 Fed. Cl. 310 (Fed. Cl. 2011). “" 21 C.F.R. 312.85(2004). . Again, this "control” vaccine caused seizures, lending to the increased concern about Prevnar which had twice as many seizures.”
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