FDA: Special Protocol Assessment Guidance for Industry

This guidance provides information on the procedures and general policies adopted by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for special protocol assessment (SPA). SPA is a process in which sponsors2 may request to meet with FDA to reach agreement on the design and size of certain clinical trials, clinical studies, or animal trials3 (i.e., a Request for SPA (Request); see section III., Eligible Protocols and General Information) to determine if they adequately address scientific and regulatory requirements. As part of this process, sponsors should submit specific questions about protocol design and scientific and regulatory requirements. After FDA completes the SPA review, FDA issues an SPA Letter including an assessment of the protocol, agreement or nonagreement with the proposed protocol, and answers to the sponsor’s relevant questions.

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