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FDA Update
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The U.S. Food and Drug Administration (FDA)
is hosting the Generic Drug User Fee Amendments (GDUFA) of 2012; Public Hearing on Policy Development to solicit public comment on certain topics related to implementation of GDUFA and the GDUFA Commitment Letter that accompanies the legislation.

FDA requests input on the five draft guidance documents FDA has issued or will issue shortly to facilitate implementation of GDUFA. FDA also seeks input on additional policy priorities under GDUFA, such as the Agency’s consideration of generic drug exclusivity and the category of first generics.
 
The meeting will be held near FDA’s main campus at College Park Marriott Hotel and Conference Center, 3501 University Blvd., East, Hyattsville, MD 20783, MD, on September 17, 2014, from 9:00am-5:00pm.
 
Submit electronic or written requests to make oral presentations by September 3, 2014 and presentation materials are due by September 9, 2014, to
GenericDrugPolicy@fda.hhs.gov.  Electronic or written comments will be accepted until October 13, 2014.
 
For more information and the latest events regarding GDUFA, please visit FDA's
Generic Drug User Fee Amendments of 2012 website. FDA will post meeting materials as they become available here. 

Number of Recalls Surges at FDA

According to the Regulatory Affairs Professional Society (RAPS), the recalls of pharmaceutical products have surged in recent years, and 2014 is already shaping up to be the biggest year for serious drug recalls in the last decade, according to data made publicly available by the U.S. Food and Drug Administration (FDA) late last month.

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