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…
Little Leaf Farms Announces Limited Voluntary Withdrawal of a Specific Lot Code of Southwest Salad Kit Due to Undeclared Fish and Wheat
Little Leaf Farms is voluntarily recalling a specific lot code of its Southwest Salad Kits due to the potential presence…
CFOs sharpen focus on supply chain strategies amid tariff threat: BDO
Despite the potential costs from import duties, “CFOs remain optimistic about growth overall,” a BDO executive said.
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…
AI’s supply chain potential among Manifest 2025 takeaways
Target and Unilever are among the companies capitalizing on artificial intelligence, but some are still struggling in areas like leveraging…