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

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…

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…

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…

Former Intel directors warn Trump’s TSMC plan would cripple US chip industry

Speculation has swirled for over a week about a potential collaboration between Intel and TSMC, igniting reactions from Intel’s current…

PCB giant Zhen Ding appoints semiconductor expert as general manager to lead smart manufacturing

PCB manufacturer Zhen Ding Tech has announced that its board of directors has officially approved the appointment of Professor Chen-Fu…