Zdrowie i gospodarka · 04/08/2000

Prescription Drug User Fee Act (PDUFA); Public Meeting

The Food and Drug Administration (FDA) is announcing its intention to hold a public meeting on the Prescription Drug User Fee Act (PDUFA). The legislative authority for PDUFA expires at the end of September 2002, and without further legislation the fees and resources provided under PDUFA will also expire. FDA is now considering what features it should advocate in proposing new or amended authorizing legislation. Section 903(b) of the Federal Food, Drug, and Cosmetic Act encourages FDA to consult with stakeholders, as appropriate, in carrying out agency responsibilities. Accordingly, FDA will convene a public meeting to hear stakeholder views on this subject. FDA is proposing four specific questions, and the agency is interested in responses to these questions and any other pertinent information stakeholders would like to share.