Review

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Order Code RS22814 February 21, 2008 FDA Fast Track and Priority Review Programs Susan Thaul Specialist in Drug Safety and Effectiveness Domestic Social Policy Division Summary By statutory requirements and by regulation, guidance, and practice, the Food and Drug Administration (FDA) works with several overlapping yet distinct programs to get to market quickly new drug and biological products that address unmet needs. FDA most frequently uses three mechanisms for that purpose: Accelerated Approval, Fast Track, and Priority Review. The first two affect the development process before a sponsor submits a marketing application. Accelerated Approval allows surrogate endpoints in trials to demonstrate effectiveness and is…show more content…
105-115) directed the Secretary to create a mechanism whereby FDA could designate as “Fast Track” certain products that met two criteria. First, the product must concern a serious or life-threatening condition; second, it has to have the potential to address an unmet medical need. Once FDA grants a Fast Track designation, it encourages the manufacturer to meet with the agency to discuss development plans and strategies before the formal submission of an NDA/BLA. The early interaction can help clarify elements of clinical study design and presentation whose absence at NDA/BLA submission could delay approval decisions. However, FDA makes similar interactions available to any sponsor who seeks FDA consultation throughout the stages of drug development. A unique option within Fast Track is the opportunity to submit sections of an NDA/BLA to FDA as they are ready, rather than the standard requirement to submit a complete application at one time.4 2 Other options fit very limited situations and support shorter times from idea to approved public use. The Animal Efficacy Rule (21 CFR 314 Subpart I and 21 CFR 601 Subpart H) allows submission of data from animal studies of effectiveness as evidence to support applications of certain new products “when adequate and well-controlled clinical studies in humans cannot be ethically conducted and field efficacy studies are not feasible.” The Project
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