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A Pharmacist Fulfilling A Prescription

Evolving nature of evidence required by FDA to approve new drugs

This brief, based on systematic reviews conducted in collaboration with the Program on Therapeutics, And Law (PORTAL), provides background on the evidence required by the Food and Drug Administration (FDA) to support drug approval. It highlights changes in the amount and extent of preapproval effectiveness and safety testing as well as the quality and timeliness of required post-market studies. It then offers a variety of policy options.

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