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Emerging Sponsors And FDA: Will Better Communication Under PDUFA V Ease Inherent Tensions?

 
• By Sue Sutter

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.

FDA and industry are hopeful that new communication mechanisms built into the Prescription Drug User Fee Act V agreement will aid small, emerging companies’ ability to bring drugs to market. Yet, it seems these new interactions may go only so far in easing the various regulatory, economic and public relations tensions between agency staff and sponsors.

Discussion by FDA, biotech and venture capital representatives at Elsevier Business Intelligence’s FDA/CMS Summit on Dec. 8-9 highlighted a number...

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