title: FDA Regulation of Prescription Drugs.
authors.affiliation: From the Division of Bone, Reproductive, and Urologic Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD.
authors.forename: Audrey L
authors.initials: AL
authors.lastname: Gassman
authors.affiliation: From the Division of Bone, Reproductive, and Urologic Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD.
authors.forename: Christine P
authors.initials: CP
authors.lastname: Nguyen
authors.affiliation: From the Division of Bone, Reproductive, and Urologic Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD.
authors.forename: Hylton V
authors.initials: HV
authors.lastname: Joffe
mesh_terms: D017277:Drug Approval; D004348:Drug Labeling / Q000331:legislation & jurisprudence / Q000592:standards; D033161:Government Regulation; D055553:Prescription Drugs; D011358:Product Surveillance, Postmarketing; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D055553:Prescription Drugs