PDUFA Provides Opportunity For Conditional Approvals, Consumer Groups Say
Executive Summary
Consumer groups are advocating the creation of a "conditional" approval authority for FDA through the reauthorization of the Prescription Drug User Fee Act
You may also be interested in...
Drug R&D Models Will Change Drastically By 2020, PwC Report Predicts
The pharmaceutical industry is about to face a world in which successful companies no longer focus on blockbusters, drugs are approved in stages for an ever widening patient population, and large sales teams have been replaced by advisers, according to a report by PricewaterhouseCooper
Drug R&D Models Will Change Drastically By 2020, PwC Report Predicts
The pharmaceutical industry is about to face a world in which successful companies no longer focus on blockbusters, drugs are approved in stages for an ever widening patient population, and large sales teams have been replaced by advisers, according to a report by PricewaterhouseCooper
PDUFA IV Is “Golden Opportunity” To Improve Drug Safety Funding And Staff
The current round of reauthorization of the Prescription Drug User Fee Act presents a "golden opportunity" to improve FDA's regulation of drug safety, according to the Institute of Medicine's Assessment of the U.S. Drug Safety System Committee