The Generic Drug User Fee Amendments, designed to facilitate the delivery of safe and effective generic drugs to the public and improve the predictability of the ANDA assessment process, has undergone ...

The Food and Drug Administration (FDA) human medical product user fee programs, covering prescription drugs (PDUFA), medical devices (MDUFA), ...

The US Food and Drug Administration (FDA) on Friday began the reauthorization process for the next iteration of the Generic Drug User Fee Amendments (GDUFA IV) with a public meeting to gather input ...

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 ...

On September 1, the Food and Drug Administration issued draft guidance for post-warning letter meeting requests under the Generic Drug User Fee Amendments. Our FDA Compliance & Enforcement Team ...

Q&A on GDUFA implementation with Aloka Srinivasan, PhD, a principal consultant with Parexel and former team leader in FDA's Office of Generic Drugs. On July 9, 2012, the Generic Drug User Fee Act ...

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 ...

The Generic Drug User Fee Act seeks to improve and enhance regulatory activities, including achieving parity of inspections between foreign and domestic drug-manufacturing sites for both finished ...

The FDA has posted draft guidance to prepare for a GDUFA-driven surge in data on the generic drug supply chain. And it is a familiar scenario, with the FDA drawing heavily on the 2009 electronic drug ...