Frequently Asked Questions on Benzene Contamination in Drugs
FDA provides answers to frequently asked questions on benzene contamination in drugs
FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use
[03-03-2015] The U.S. Food and Drug Administration (FDA) cautions that prescription testosterone products are approved only for men who have…
FDA Roundup: February 28, 2025
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
FDA issues class-wide labeling changes for testosterone products
FDA issues labeling changes for all testosterone products following conclusion of ambulatory blood pressure monitoring studies and TRAVERSE trial,
Generic Drugs Program Activities Report – FY 2024 Monthly Performance
This report provides monthly activities metrics for the FDA Generic Drugs Program, outlining agency actions on abbreviated new drug applications.…
Generic Drugs Program Monthly and Quarterly Activities Report
Monthly and quarterly metrics of the FDA Generic Drugs Program.
Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions – 03/13/2025
Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions
Prescription Drug User Fee Amendments
The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from…
UPDATED MEETING TIME AND PUBLIC PARTICIPATION INFORMATION: December 4, 2024: Meeting of the Pharmacy Compounding Advisory Committee – 12/04/2024
This meeting is scheduled to start at approximately 8 a.m. Eastern Time and will be held at FDA White Oak…
Global Trends and Methodological Challenges in Hair Toxicology: A Survey‐Based Analysis
Drug Testing and Analysis, EarlyView.