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FDA CDRH Portal Now Offers Tracking of Pre-Submissions On May 22, the FDA announced that it has updated the CDRH Portal to allow users to track the progress of Pre-Submissions. A submitter must specify the type of Pre-Submission request, which include: written feedback (only) written feedback followed by a meeting The agency noted that the …
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FDA Releases Two Discussion Papers on Artificial Intelligence and Machine Learning in Drug Development and Manufacturing On May 10, the FDA released two discussion papers on the use of artificial intelligence and machine learning (AI/ML) in drug development and manufacturing. In a statement introducing the papers, Patrizia Cavazzoni, M.D., Director of the FDA Center …
CDRH Launches Pilot Program To Reduce Device Approval Times The FDA Center for Devices and Radiological Health (CDRH) is launching the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot. “TAP is a voluntary program intended to de-risk the medical device valley of death by providing industry with earlier and more frequent interactions with …
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CDRH Seeks Medical Device Sites for Review Staff Education To help reviewers keep pace with rapid advances in medical devices and technologies, the FDA’s Center for Devices and Radiological Health (CDRH) developed the Experiential Learning Program (ELP). ELP provides CDRH review staff with an opportunity to visit sites and gain a better understanding of …
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