GDUFA Commitments Won’t Be Met If Congress Nixes White Oak Funding
Executive Summary
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.
You may also be interested in...
FDA’s Budget Proposal: It’s The User Fees’ Agency Now
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.
GDUFA Self-Identification Woes Can’t Deflate Industry, FDA Enthusiasm
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.
CBER Strategic Plan Showcases New Lab Complex, Research Projects For Cancer, Rare Diseases
Center for Biologics Evaluation and Research describes the Life Sciences-Biodefense Laboratory scheduled for completion in December 2013 and its plans to facilitate development of safe and effective products.