Special Protocol Assessment; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Special Protocol Assessment.'' This draft guidance provides information about the procedures and general policies adopted by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics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). This draft guidance is intended to improve the quality of Requests for SPAs and accompanying submission materials, and the quality of the resulting interaction between sponsors and FDA. This draft guidance revises the guidance for industry entitled ``Special Protocol Assessment'' issued May 17, 2002.