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Gottlieb Q&A: Confirmation Is Nearing, Will Complete Response Letters Finally Get Released?

Executive Summary

Gottlieb favors making the letters detailing application problems public, but industry still may oppose it; Senate schedules cloture vote for confirmation.

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

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.

Complete Response Letters: US FDA Trying To Identify Subsets For Public Release

Agency want to identify a 'manageable' subset of letters for release in which drug approval was denied for reasons, such as safety concerns, that can help inform clinical practice and impact public health, Commissioner Gottlieb says, adding: 'I'm not sure that that's doable. I'm inclined to think that it might be.'

Complete Response Letters: Firms See Value In Public Release, Don't Expect It Will Happen

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