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 […]

Docket Number: FDA-1993-D-0184 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The FDA published Good Guidance Practices in February 1997. This guidance was […]

Issued by: Guidance Issuing Office Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice FDA Guideline […]

For Immediate Release: January 30, 2025 Today, the U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat […]

Were there any differences in side effects of the clinical trials among sex, race, and age groups? Adverse reactions through Week 16 of the placebo-controlled trials […]

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this […]