The U.S. Food and Drug Administration (FDA) released two draft commitment letters containing numerous recommendations and commitments made ...

In a public meeting held via webcast, officials of the US Food and Drug Administration (FDA) kicked off the process for reauthorizing the Generic Drug User Fee Amendments (GDUFA). The meeting, which ...

The US Food and Drug Administration (FDA) published a final guidance last week that updates the agency’s user fee structure and other aspects of the Generic Drug User Fee Amendments (GDUFA III) deal ...

The author discusses the key provisions of GDUFA as they relate to the pharmaceutical supply chain, including parity of inspections between domestic and foreign sites for both finished dosage forms ...

Day Two of the open GPhA Annual Meeting featured a panel on FDA and industry perspectives on a quality culture. Janet Woodcock, M.D., Center Director, Center for Drug Evaluation and Research (CDER) ...

The Food and Drug Administration is raising the fees that generic drug companies will have to pay when filing for regulatory approval for new products or supplemental applications for existing ...