Category Archives: Advisory Committee Prepapartion

FDA Adds New AdComm to Address Genetic Metabolic Diseases

Back in December 2023, FDA announced intention in the Federal Register and in a press release to form a new FDA Advisory Committee to be called the Genetic Metabolic Diseases Advisory Committee (GeMDAC). As noted in a recent posting here, … Continue reading

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The Year in AdComms – A Look Back at 2023

For those working closely with the development of new medicines for FDA approval, it can be informative respecting the future to look back at recent activity and take note of any potential changes from years past. Now, with no more … Continue reading

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FDA Launching New Advisory Committee on Digital Health

FDA announced this week the formation of a new advisory committee – the Digital Health Advisory Committee – for the purpose of providing the agency with advice on matters related to digital health technologies (DHT). FDA does not form new … Continue reading

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Drug Approvals and FDA AdComms in 2023

Having passed the mid-year point, it is always an interesting exercise to take stock of where we stand with respect to the approval of new medicines. Overall, when considering the volume of activity, things would seem to be looking up … Continue reading

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Thumbs Up, Thumbs Down – Minimizing Votes in AdComms

The FDA Commissioner has said he would like to limit votes in AdComms – is that really a good idea? Continue reading

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