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Clinical Trials and the Food and Drug Administration

Tarek M. Mahfouz, Janelle S. Crossgrove

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Abstract

Abstract The Food and Drug Administration (FDA) protects the health of Americans by enforcing the Federal Food, Drug, and Cosmetic Act and other related public health laws. The role of the FDA in clinical trials is to help protect the rights and welfare of the patients participating in the trial. This article discusses the different steps a new drug goes through before it is marketed and the involvement of the FDA in each step.

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What this paper is about

Abstract The Food and Drug Administration (FDA) protects the health of Americans by enforcing the Federal Food, Drug, and Cosmetic Act and other related public health laws. The role of the FDA in clinical trials is to help protect the rights and welfare of the patients participating in the trial. This article discusses the different steps a new drug goes through before it is marketed and the involvement of the FDA in each step.

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Available abstract

Abstract The Food and Drug Administration (FDA) protects the health of Americans by enforcing the Federal Food, Drug, and Cosmetic Act and other related public health laws. The role of the FDA in clinical trials is to help protect the rights and welfare of the patients participating in the trial. This article discusses the different steps a new drug goes through before it is marketed and the involvement of the FDA in each step.

Key concepts: Food and drug administration, Clinical trial, Drug, Administration (probate law), Welfare, Medicine, Drug administration, Clinical research

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