PDUFA IV Negotiations Underway With FDA, Industry Working In Harmony
Executive Summary
PhRMA will pursue earlier postmarketing commitment negotiations with FDA as part of a limited industry agenda for the third reauthorization of the Prescription Drug User Fee Act
You may also be interested in...
FDA Opposes Enzi/Kennedy Drug Safety Bill; Action More Likely Through PDUFA
Pending drug safety legislation from Sens. Michael Enzi (R-Wyo.) and Edward Kennedy (D-Mass.) may do more harm than good, FDA implied in comments submitted to the Senate Health Committee
FDA Opposes Enzi/Kennedy Drug Safety Bill; Action More Likely Through PDUFA
Pending drug safety legislation from Sens. Michael Enzi (R-Wyo.) and Edward Kennedy (D-Mass.) may do more harm than good, FDA implied in comments submitted to the Senate Health Committee
BIO, PhRMA Oppose Granting FDA Authority To Mandate Postmarket Studies
The Pharmaceutical Research & Manufacturers of America and the Biotechnology Industry Organization oppose granting FDA the power to require postmarketing studies