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Characterization Of The Physical Properties And The Bioavailability Of Phenobarbital Tablets, Usp, 100 Mg, Mario F. Sylvestri

University of the Pacific Theses and Dissertations

The Food, Drug, and Cosmetic Act of 1938 required a producer of a new drug to substantiate the safety of the drug product when used as recommended; however, the introduction of the Kefauver-Harris Amendments of 1962 considerably strengthened this act. These amendments intensified the controls on quality, labeling, and safety, while adding a new requirement that all NDA's should be able to present substantial evidence of the effectiveness of the drug product for its indicated use of uses (4). The procedure used to determine the efficacy of a drug included identification of the product, copies of the labeling, and a …