US FDA’s 2022 Novel Agent Actions Suggest Acceleration In Use Of Complete Response Letters
COVID does not appear to be a driving factor, and letters are split almost equally between clinical and quality concerns.
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Will 2022 Be US FDA’s Year Of ‘No’? Approval Rate For Novel Agents Plunged In First Half
With 19 novel approvals and 14 complete response letters in the first half of 2022, the year is shaping up to be a turnabout from the big approval counts and rare CRLs of the recent approvals boom years.
US FDA’s Califf Notes ‘Price To Pay’ For Missed Inspections During Senate COVID Funding Hearing
As Senate HELP Committee meetings questioned Commissioner Califf about backlog of inspections and FDA staff continuing to work remotely, Sen. Burr promises to be a roadblock to emergency COVID-19 funding.
US FDA’s Califf Acknowledges There Is ‘Price To Pay’ For Missed Inspections
Commissioner Califf is questioned about the backlog of inspections and fact FDA staff are continuing to work remotely at Senate HELP Committee hearing. Senator Burr promises to be a roadblock to emergency COVID-19 funding.