Federal Register Notice: FDA is making available three guidances for industry entitled Premarketing Risk Assessment, Development and Use of Risk Minimization Action Plans, and Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. These guidances provide guidance to industry on risk management activities for drug products, including biological drug products, CDER and CBER. Click on the guidance name above to download the guidance. To view this notice, click here.
