Tag Archives: GDUFA

Implementing the Generic Drug User Fee Act: Struggles and Successes

Two years into the Generic Drug User Fee Act (GDUFA) program, enacted in July 2012, FDA officials are striving to meet goals and timelines for speeding new generic drugs to market. Agency reviewers have made some progress in eliminating the huge backlog in abbreviated new drug applications (ANDAs) pending in the Office of Generic Drugs […]
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New Fees Made FDA Worse for Generic Drug Approvals, Says GPhA Chairman

‘Actions’ don’t speak louder than words in dealing with FDA’s backlog of generic drug applications, says newly-elected GPhA Board Chairman Craig Wheeler. When the Generic Drug User Fee Act (GDUFA) was signed into law on July 7, 2012, its primary intent was to provide FDA with the additional resources necessary to expedite the review process […]
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Budget policies jeopardize FDA funding, user fees

Budget policies jeopardize FDA funding, user fees Even though Congress authorized both existing and new user fees for the Food and Drug Administration several months ago through the FDA Safety & Innovation Act (FDASIA), efforts to cut the federal deficit raises questions about how those fees will be collected and used in the coming year. […]
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