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Single Database Of FDA Actions Could Improve Drug Development, Sanofi Says

 
• By Brenda Sandburg

Sanofi exec advocates development of comprehensive dataset of US FDA regulatory processes and outcomes to enable sponsors to anticipate agency expectations.

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The US Food and Drug Administration asked stakeholders for specific recommendations on what it can do to improve the drug development process. Sanofi offered one proposal: work in partnership with industry and academia to develop a reliable, quality dataset that would capture regulatory processes, outcomes, and metrics.

Sanofi's Andrew Robertson, head of regulatory science and policy for North America, spoke at a 7 November FDA meeting titled "Promoting Effective Drug Development Programs: Opportunities and Priorities for FDA's...

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