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Complete Response Letters: Industry Prefers Communication Before Rather Than Docs After

 
• By Derrick Gingery

Rep. Dunn’s idea would be a return to prior agency practice; the documents are currently considered exempt from disclosure.

File with padlock
The FDA used to offer review documents to sponsors who received CRs . • Source: Alamy

Rep. Neal Dunn continues pushing to disclose all review documents to sponsors after they receive a complete response letter even though industry officials, in addition to the US Food and Drug Administration, do not seem overly supportive.

Representatives of the Pharmaceutical Research and Manufacturers of America and Biotechnology Innovation Organization, two influential trade groups, chose to focus...

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