FDA requests input on the five draft guidance documents FDA has issued or will issue shortly to facilitate implementation of GDUFA.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.
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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