Biosimilar, Generic and Rx User Fees Rely On Different Adjusters For Needed Appropriations
The biosimilar and generic drug user fees use different CPI measures, meaning they could increase the appropriations needed to allow user fee collection at different rates.
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Biosimilars: Does Low BsUFA Fee Revenue Suggest Sponsor Interest Has Stalled?
Halfway through the first year of the biosimilar user fee program, fee payments have not lived up to the expectation in President Obama’s FY 2013 budget request. Initial meetings continue to grow but at a slow pace, suggesting sponsors may remain hesitant about the pathway.
Accelerated Approval Could Expand As Alternative To Progressive Approval
CDER Director Woodcock says agency should issue internal and external guidance to promote consistent use of the pathway.
Burgess Not Changing Conflict Of Interest Thinking Despite Flap Over Oral Contraceptive AC
Sponsor of bill that would adjust conflict of interest rules says requiring public release of financial disclosure documents, as one group suggested, may not require a legislative fix.