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US FDA May Scrap Clinical Study Report Disclosure For New Drug Approvals

 
• By Derrick Gingery

The pilot project former Commissioner Gottlieb championed found only one sponsor interested in participating.

FDA entrance sign 2016
The FDA may shift its focus on improving approval transparency to the integrated review document template instead. • Source: File photo

The US Food and Drug Administration may give up on a program to release clinical study reports and instead pin hopes of increasing public understanding of new drug approvals on shortened review documents.

After only one sponsor agreed to participate in the clinical study report disclosure pilot program, the agency said in a Federal Register notice the integrated review document may better...

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