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 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 ...

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 ...

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The FDA has posted draft guidance to prepare for a GDUFA-driven surge in data on the generic drug supply chain.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 ...

In a congressional cycle paralyzed by partisan gridlock, early reauthorization of PDUFA--the Prescription Drug User Fee Act--was hailed as a triumph for the current Congress. Not only did the law pass ...