Endothelin Receptor Antagonist REMS Information
FDA has determined that a REMS is no longer necessary to ensure ERA medicines’ benefits outweigh the risk of EFT.
Check Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers
Prescription drugs should only be purchased from wholesale drug distributors licensed in the United States. Verify licensing through FDA database…
Public Meeting on the Reauthorization of Generic Drug User Fee Amendments (GDUFA) – 07/11/2025
FDA is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments…
Structural Characterization of Nitazene Analogs Using Electrospray Ionization–Tandem Mass Spectrometry (ESI–MS/MS)
Diagnostic ions and trends were identified for 38 nitazene analogs structurally characterized using electrospray ionization–tandem mass spectrometry with a high-resolution…
Exela Pharma Sciences, LLC – 709859 – 07/02/2025
CGMP/Finished Pharmaceuticals/Adulterated
Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations
Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations
Self‐Reported Use of Thyroid Hormones by Athletes at the Olympic Games
This study of 9832 athletes at three Olympic Games found that self-reported thyroid hormone use is more common than in…
FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations
On July 2, 2025, the Food and Drug Administration granted accelerated approval to sunvozertinib (Zegfrovy, Dizal (Jiangsu) Pharmaceutical Co., Ltd.)…
Novel Drug Approvals for 2023
Each year, CDER approves a wide range of new drugs and biological products.
List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic
The FDA maintains a list of approved new drug application (NDA) drug products that are no longer protected by patents…