FDA Review and Approval Process

Before any drug is approved for marketing, the FDA reviews the data provided for the new drug candidate in BLA or NDA submissions and evaluates the benefits and risks of the new drug. The data in BLA or NDA submissions are reviewed by one of two branches within the FDA—the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER)—with the help of advisory panels. On completion of the review the FDA decides whether to approve the new drug, request more information, require new studies, or grant accelerated (conditional) approval (Box 4.7). On approval the FDA may request the drug's sponsor to carry out postmarketing (phase IV) studies to gather long-term data.

FDA advisory panels in specific therapeutic areas play an important role in the drug approval process. More often than not, FDA staff ask the expert members of the panel for guidance on key questions related to the safety and efficacy of the new drug candidate, and sometimes on more technical questions such as the design of clinical trials. At the conclusion of their deliberations, panel members vote to recommend or not recommend that the agency approve the new drug based separately on efficacy and safety issues; the panel also advises the regulatory agency on appropriate use of the drug, including limitations as to the indicated patient population and other safeguards. While the FDA values the advice of its advisory panels, the final decision to approve or not approve a

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