January 31, 2025
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 […]
January 31, 2025
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 […]
January 31, 2025
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 […]
January 31, 2025
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 […]
January 31, 2025
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 […]
January 31, 2025
Research Pending Peer Review and Publication | Office of Prescription Drug Promotion (OPDP) 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 […]
January 31, 2025
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended that marketing authorizations be approved for three new cancer drugs: […]
January 31, 2025
The US Food and Drug Administration (FDA) has approved a novel formulation combining rizatriptan and the nonsteroidal anti-inflammatory drug meloxicam (Symbravo, Axome Therapeutics) for the acute […]
January 31, 2025
The European Medicines Agency (EMA) announced it will review new safety data on the Alzheimer’s disease drug Leqembi (lecanemab). This follows a prior decision to recommend […]
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