The Drug Amendment to the FDCA gives the FDA broad powers to license new drugs in the United States.

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The Drug Amendment to the FDCA, also known as the Kefauver-Harris Amendment, gave the FDA broad powers to license new drugs in the United States. It established requirements for proof of safety and efficacy before a drug could be approved and also mandated that drug manufacturers provide full disclosure of potential side effects and dangers associated with their products.

The Drug Amendment to the FDCA Gives the FDA Broad