PDUFA III Critics Face Uphill Fight To Keep Bill Out Of Bioterrorism Package
Executive Summary
Critics of the PDUFA III compromise are facing an uphill struggle to keep the bill out of the bioterrorism conference agreement
You may also be interested in...
PDUFA III Authorizes FDA To Alert MDs To Failed Phase IV Commitments
FDA will have the authority to require manufacturers to inform prescribers if they fail to complete Phase IV commitments under the Prescription Drug User Fee Act reauthorization
PDUFA III Authorizes FDA To Alert MDs To Failed Phase IV Commitments
FDA will have the authority to require manufacturers to inform prescribers if they fail to complete Phase IV commitments under the Prescription Drug User Fee Act reauthorization
Rx Industry CEOs Are Taking “Positive” Steps On GMPs, FDA’s Galson Says
FDA's discussions with pharmaceutical industry CEOs over the past year give the agency confidence that manufacturing quality is improving, Center for Drug Evaluation & Research Deputy Director Steven Galson, MD, told the Schwab Washington Research Group conference May 2