FDA Expedited Program for serious conditions – Special Protocol Assessment

Published by IRDiRC

Regulatory AffairsClinical DevelopmentClinical Trial DesignRegulatory AdviceSpecial Protocol Assessment

FDA-SPA is a process in which sponsors may ask to meet with FDA to reach agreement on the design and size of certain clinical trials, clinical studies, or animal studies, to determine if they adequately address scientific and regulatory requirements for a study that could support marketing approval.

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