Press Releases Are ‘Incomplete Substitutes’ For FDA Letters
Executive Summary
FDA analysis finds few matches between ‘complete response’ letters, press releases. But few specific factors about sponsors and NDAs could clearly be shown to be predictive of disclosure.
You may also be interested in...
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.'
End Of US FDA’s Very Fast Reviews? 2022 Novel Approvals Stayed Close To PDUFA Timeframes
Moderation was a theme of the year in novel approvals, as CDER’s median review time rose for the first time in five years and even the center’s fastest approval took more than seven months. A Pink Sheet infographic breaks down which review pathways did the best last year.