FDA's new drug evaluation process: a general overview.

P G Walters

doi:10.1111/j.1752-7325.1992.tb02298.x

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FDA's new drug evaluation process: a general overview.

P G Walters

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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.

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Chemical Phenomena Chemistry Clinical Trials as Topic Drug Approval Drug Evaluation Drug Therapy Drugs, Investigational Humans Pharmacology United States United States Food and Drug Administration Journal Article

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P G Walters. 1992. FDA's new drug evaluation process: a general overview.. https://doi.org/10.1111/j.1752-7325.1992.tb02298.x

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