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US FDA To Publish Own Datasets In Latest Signal Of Enhanced Transparency

 
• By Michael Cipriano

Adverse event reporting data will also be more readily available, Commissioner Scott Gottlieb says.

The US FDA is looking to routinely publish clinical data used in regulatory decision making along with adverse event reporting data, in what appears to be just the latest effort of Commissioner Scott Gottlieb's high profile effort to enhance transparency at the agency.

Speaking at the POLITICO Pro Summit Sept. 14, Gottlieb explained that sometimes FDA develops its own datasets based on submitted...

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