Guidance for Pharmacovigilance Planning

The FDA’s Center for Drug Evaluation and Research (CDER) posted notice of the publication of a guidance on the planning of pharmacovigilance activities, especially in preparation for the early postmarketing period of a new drug (NCEs, biotech products, vaccines). This guidance can be used to develop a stand-alone document for regions that prefer this approach or to provide guidance on incorporation of elements of the safety specification and pharmacovigilance plan into the Common Technical Document (CTD). See InfoClick for more details.