Counterfeit Medicine
Counterfeit (fake or falsified) medicines may be harmful to your health because while being passed off as authentic, may contain…
FDA grants accelerated approval to the combination of avutometinib and defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer
On May 8, 2025, the Food and Drug Administration granted accelerated approval to the combination of avutometinib and defactinib (Avmapki…
FDA CDER Overview: Certificates of Confidentiality – 05/07/2025
FDA CDER Overview: Certificates of Confidentiality
Skin Beauty Solutions – 683006 – 07/25/2024
Finished Pharmaceuticals/Unapproved New Drugs
Matte Beauty – 679463 – 07/25/2024
Finished Pharmaceuticals/Unapproved New Drugs
Repare Skincare – 680247 – 07/25/2024
Finished Pharmaceuticals/Unapproved New Drugs
ISIS.GOLD – 679948 – 07/25/2024
Finished Pharmaceuticals/Unapproved New Drugs
Walmart, Inc. – 683095 – 07/25/2024
Finished Pharmaceuticals/Unapproved New Drugs
Amazon.com, Inc. – 679523 – 07/25/2024
Finished Pharmaceuticals/Unapproved New Drugs
CDER Emerging Drug Safety Technology Program (EDSTP)
The EDSTP is specifically focused on the use of artificial intelligence and other emerging technologies in pharmacovigilance and is part…