Final PDUFA Recommendations Transmitted to Congress Will Strengthen Drug Review and Drug Safety
PDUFA provides user fee funds, paid by brand drug and biotechnology companies that are added to appropriated funds to support the review of new human drugs. Since 1992, when PDUFA was first enacted, FDA has provided the public with 1,220 new drugs and biologics. The current user fee program is scheduled to expire on September 30, 2007.