Zdrowie i gospodarka · 17.05.2002
Guidance for Industry on Special Protocol Assessment; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Special Protocol Assessment." This guidance provides guidance for industry on procedures 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.