Post-Marketing Safety Studies Could Be Funded By User Fees, Cmte. Suggests
User fees to fund post-marketing safety assessments should be considered in negotiations for the reauthorization of the Prescription Drug User Fee Act, a former FDA official and member of the Drug Safety & Risk Management Advisory Committee suggested
You may also be interested in...
The Center for Postmarket Drug Evaluation & Research proposed in legislation from Sens. Grassley and Dodd would be funded by appropriations, not user fees
Postmarketing safety legislation proposed by Senate Finance Committee Chairman Charles Grassley (R-Iowa) and Sen. Chris Dodd (D-Conn.) calls for FDA to establish "expedited procedures" for drug withdrawals
The pharmaceutical industry had 67% fewer drugs and biologics with open Phase IV commitments in fiscal year 2004 than the previous year, FDA's postmarketing database shows