The FDA Maze.

J Levy

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PubMed · 7035076

The FDA Maze.

J Levy

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Abstract

The testing of new dermatologic pharmaceutical formulations is a long and expensive process. The subsequent regulatory submissions to the Food and Drug Administration (FDA) involve considerable detail and negotiations. Most dermatologists have only a superficial knowledge of the processes involved in proving the safety and efficacy of new drugs. This article is an attempt to impart a greater understanding of the procedures involved in obtaining FDA approval of new pharmaceutical entities.

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Animals Clinical Trials as Topic Dermatologic Agents Drug Evaluation Drug Evaluation, Preclinical Humans Legislation, Drug Pharmacology Reproduction Research Safety United States United States Food and Drug Administration Clinical Trial Journal Article

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J Levy. 1982. The FDA Maze.. https://pubmed.ncbi.nlm.nih.gov/7035076/

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