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FDA Deputy On CRLs: 'It's Not Our Property To Release'

 
• By Jessica Merrill

US FDA Principal Deputy Commissioner Rachel Sherman said during the BIO CEO & Investor conference that while investors and others would like to see complete response letters, the agency's hands are bound when it comes to their full release. Sherman also commented on FDA's focus for right-to-try legislation.

FDA entrance sign 2016

Investors, public health advocates and other drug industry stakeholders would like to see the full contents of FDA complete response letters, but Principal Deputy Commissioner Rachel Sherman threw some cold water on the possibility during a talk at the BIO CEO & Investor Conference.

"It's not our property to release – unless there is a real public health issue," Sherman said on Feb. 13, responding to a question from an investor in attendance who...

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