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

 
• By Sue Sutter

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.'

Hand opens curtain to beautiful day

US FDA Commissioner Scott Gottlieb is laying the groundwork for public disclosure of complete response letters (CRLs) driven by safety or other concerns with "significant public health value" – a move that could at least partially lift the veil on why drug applications fail to gain the regulator's nod.

The agency is trying to identify a "manageable" subset of CRLs in which approval was denied for reasons that can...

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