Zdrowie i gospodarka · 9.02.2000
Draft Guidance for Industry on Special Protocol Assessment; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Special Protocol Assessment." This draft guidance is intended to provide guidance for industry on procedures that will be adopted by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) to evaluate issues related to the adequacy (e.g., design, conduct, analysis) of certain proposed studies.