Zdrowie i gospodarka · 04/05/2016

FDA Releases Draft Guidance for Industry on Special Protocol Assessment

The Food and Drug Administration (FDA) has released a draft guidance for industry titled "Special Protocol Assessment," which outlines procedures and policies for special protocol assessments (SPAs) by the FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). The revised guidance aims to enhance the quality of Requests for SPAs and interactions between sponsors and the FDA.