EFCG Ratifies FDA's Proposed Generic Drug User Fees Act

The European Fine Chemicals Group (EFCG; Brussels) says its board has agreed to ratify the proposal of the U.S. Food and Drug Administration (FDA) to put forward a legislative package, designed with the help of EFCG and U.S. industry representatives, to deliver into U.S. law, a new generic drug user fees act (GDUFA). GDUFA requires the FDA to commit to significantly improve its regulatory activities for the benefit of global generic drug providers and U.S. generic drug users, in exchange for the global generics industry providing FDA with $299 million in user...

This information is only available to Chemical Week subscribers.

Forgot your user ID or password?
Click here to have it sent to you.

Email Address First Name Last Name

Not an IHS Chemical Week 24/7 member yet? Here's why you should be: Searchable online archive access of the last 2 years of Chemical Week. Print or digital magazine subscription Price and market change alerts Economic data and statistics Buyers' Guides Webcasts | whitepapers