FDA ANNOUNCES MEETING ON GENERIC DRUG USER FEE ACT

The FDA has announced a public meeting to discuss the proposed Generic Drug User Fee Act.

The Food and Drug Administration (FDA) has announced it will hold a public meeting to discuss the proposed recommendations for the Generic Drug User Fee Act (GDUFA), which will authorize FDA to collect fees and use them for the process for the review of human generic drug applications and associated Type II Active Pharmaceutical ingredient Drug Master Files (DMFs) and for conducting associated inspections for fiscal years 2013-2117.

The meeting will be held at the FDA’s White Oak Campus, Silver Spring, MD, on Monday, December 19th from 8:00am to 5:00pm ET. Registration is required to attend and must be received by December 12, 2011. The meeting will also be webcast.

For more information, please view the Federal Register announcement: http://www.gpo.gov/fdsys/pkg/FR-2011-12-08/html/2011-31630.htm

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