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Latest posts
Last updated about 13 hours ago
FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
about 14 hours ago
Full prescribing information for Keytruda and Keytruda Qlex will be posted on...
Regulatory Science at CDER
about 18 hours ago
Explore the FDA's Center for Drug Evaluation and Research (CDER) regulatory science...
2022 Meeting Materials, Obstetrics, Reproductive and Urologic Drugs Advisory Committee (formerly Bone, Reproductive and Urologic Drugs Advisory Committee)
about 19 hours ago
2022 Meeting Materials, Obstetrics, Reproductive and Urologic Drugs Advisory Committee (formerly Bone...
iPLEDGE Risk Evaluation and Mitigation Strategy (REMS)
about 19 hours ago
The goal of the iPLEDGE REMS is to mitigate the risk of...
Questions and Answers on the iPLEDGE REMS
about 19 hours ago
Questions and Answers on the iPLEDGE REMS
CDERLearn
about 19 hours ago
Training and Education for healthcare professionals, academia, and consumers from FDA’s Center...
Biosimilars | Science and Research
about 20 hours ago
Learn about FDA’s latest in biosimilar science and research.
Boothwyn Pharmacy, LLC - 717525 - 01/16/2026
about 20 hours ago
Compounding Pharmacy/Adulterated Drug Products
Bio-Medical Pharmaceutical Manufacturing Corporation - 719654 - 02/05/2026
about 20 hours ago
CGMP/Finished Pharmaceuticals/Adulterated
Beach Weekend Management LLC dba Nic and Jet Fuel - 719715 - 02/05/2026
about 20 hours ago
Unapproved New Drugs
Signature Formulations, LLC - 718093 - 01/21/2026
about 20 hours ago
CGMP/Finished Pharmaceuticals/Adulterated