FDA Issues Draft Guidance on Special Protocol Assessments

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 05-10-2016 14:28


The US Food and Drug Administration (FDA) has issued draft guidance, Special Protocol Assessment, to specify t the procedures and general policies adopted by the Center for Drug Evaluation and Research (CDER) and the Center for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).

A SPA is a process in which sponsors may request to meet with the FDA to reach agreement on the design and size of certain clinical trials, clinical studies, or animal trials to determine if they adequately address scientific and regulatory requirements. As part of this process, sponsor should submit specific questions about protocol design and scientific and regulatory requirements. After the 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. An SPA agreement indicates concurrence by the FDA with the adequacy and acceptability of specific critical elements of overall protocol design (e.g., entry criteria, dose selection, endpoints, and planned analyses).

Source: FDA


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