Emerging Sponsors And FDA: Will Better Communication Under PDUFA V Ease Inherent Tensions?
By
Sue Sutter / Email the Author / “The Pink Sheet” Jan. 2, 2012, Vol. 74, No. 1
Regulatory Update / Word Count: 1865 / Article # 00111219020
Executive Summary
New communication mechanisms built into the Prescription Drug User Fee Act V agreement are unlikely to be the panacea for the regulatory, economic and public relations challenges created when a small company attempts to bring its first drug to market.
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