title: FDA's new drug evaluation process: a general overview.
abstract: A general overview of the FDA new-drug evaluation process is presented with special emphasis on the regulatory requirements as outlined in the federal Food, Drug, and Cosmetic Act and the interpretive New Drug Regulations. Included is a description of the administrative/scientific makeup and functions of the new-drug evaluation divisions within the Center for Drug Evaluation and Research. Some specifics relating to the investigative development of anticaries and plaque/gingivitis new drug products are discussed.
authors.affiliation: Division of Medical Imaging, Surgical and Dental Drug Products, Food and Drug Administration, Rockville, MD 20857.
authors.forename: P G
authors.initials: PG
authors.lastname: Walters
mesh_terms: D055598:Chemical Phenomena; D002621:Chemistry; D002986:Clinical Trials as Topic; D017277:Drug Approval; D004341:Drug Evaluation / Q000379:methods; D004358:Drug Therapy; D015507:Drugs, Investigational; D006801:Humans; D010600:Pharmacology; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000458:organization & administration / Q000592:standards
chemical_list: D015507:Drugs, Investigational