Generic Drugs Program Activities Report – FY 2025 Monthly Performance
This report provides monthly activities metrics for the FDA Generic Drugs Program, outlining agency actions on abbreviated new drug applications.…
Drug Trials Snapshots: BRINSUPRI
Drug Trials Snapshots: BRINSUPRI
Drug Trials Snapshots: ZEGFROVY
Drug Trials Snapshots: ZEGFROVY
Characterization of Novel Enarodustat Metabolites Using Liquid Chromatography–High Resolution Mass Spectrometry for Doping Control Purposes
Schematic illustration of enarodustat metabolites in vivo: After a single oral administration, eight metabolites were characterized using LC-HRMS, including Phase I…
Surveillance of Phenibut in Wastewater During a Brazilian Carnival
This study reports the first detection of phenibut in Brazilian wastewater. Phenibut, a substance readily sold online to improve concentration,…
Q&A on CGMP Requirements
Pharmaceutical Quality/Manufacturing Standards (CGMP)
mR.7 SUPER 700000 may be harmful due to hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use mR.7 SUPER 700000
FDA approves pembrolizumab with enfortumab vedotin-ejfv for muscle invasive bladder cancer
On November 21, 2025, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex,…
A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium – 02/13/2024
A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium
Expiration Dates – Questions and Answers
Pharmaceutical Quality Resources Expiration Dates – Questions and Answers