GDUFA Commitments Won’t Be Met If Congress Nixes White Oak Funding
President Obama’s FY 2014 budget proposal argues that Congressional failure to provide FDA with additional funding for its White Oak consolidation efforts could force GDUFA hiring to stall, jeopardizing the agency’s ability to meet the user fee commitments negotiated with industry.
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User fees, not appropriations, will make up the bulk of FDA’s human drug spending if President Obama’s FY 2014 budget comes to pass, a trend fueled by new user fee programs and cuts to taxpayer funding.
As the grace period nears its close, industry officials say they expected problems getting generic drug manufacturing facilities to self-identify under the new user fee requirement; meanwhile, FDA expects to hire nearly three times the staff in the Office of Generic Drugs to meet GDUFA commitments.
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