Zdrowie i gospodarka · 01/06/2006
FDA Withdraws and Revises Guidances for Industry
The Food and Drug Administration (FDA) is withdrawing five and revising two guidances for industry due to inconsistencies with its Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century initiative. The FDA is updating guidances related to products regulated by the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Veterinary Medicine (CVM).