FDAnews Drug Daily Bulletin

Jan. 18, 2012 | Vol. 9 No. 12

FDA Submits Generic, Brand Drug User Fee Bill Language to Congress

Generic drugmakers won’t have long to wait after Congress passes a user fee bill to learn the various fee levels in the Generic Drug User Fee Act (GDUFA). Under statutory language delivered to Capitol Hill on Friday, the FDA would have only until Oct. 31 to establish fee levels for a one-time backlog fee, a drug master file fee and various application and supplement fees.
Drug Industry Daily

Register Now
Print This Page
Email This Article
RSS
Archives

House Track-and-Trace Bill Moves to Floor Without Unit-Level Designs House Track-and-Trace Draft Leaves Unit Level Plan to FDA Senators Raise Alarm Over Hospital Pediatric Drug Shortages; FDA on the Case House Track-and-Trace Draft Leaves Unit Level Finagling to the FDA

Home
Advertising/Sponsorships
About Us
Contact Us
Site Map
Privacy Policy

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA.
Phone (703) 538-7600 - Fax (703) 538-7676 - Toll free (888) 838-5578.