Image Español Flu viruses typically spread in fall and winter, with activity peaking between December and February. Getting vaccinated in the fall can lower your chances […]

Docket Number: FDA-2021-D-1096 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The Food and Drug Administration (FDA […]

Docket Number: FDA-2004-D-0121 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This document provides guidance to industry […]

Docket Number: FDA-2011-D-0057 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance describes best practices pertaining […]

Image Español Women who are pregnant or breastfeeding often need to take prescription medications. The use of prescription medication during pregnancy and while breastfeeding has increased […]

Image By: Patrizia Cavazzoni, MD, Director, Center for Drug Evaluation and Research (CDER) and Amy Ramanadham, PharmD, MS, Staff Director of Drug Safety Operations, CDER  Every […]

Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This is one in a series of guidances that […]

OPDP’s research team is involved in many ongoing research projects. These studies will inform our understanding of important issues related to prescription drug promotion. Before research […]

The following research projects are complete and awaiting peer review and publication in scientific journals.  Study results and links to more information will be posted here […]