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 ...

Increasing the timely, safe, and cost-effective availability of generic drugs requires that excipient issues be addressed as an integral part of the process, said Priscilla Zawislak, Immediate ...

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 ...

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 ...

On July 9, 2012, the Generic Drug User Fee Act (GDUFA) was passed by the US Congress. The Act, to be implemented from Oct. 1, 2012, is designed to streamline the generic-drug review process and has ...