Author Archives: Mark Senak

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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What They Said – FDA Press Releases in 2023

Less is more? Every so often is it worthwhile to look back at FDA to see what they had to say in a given year, and in addition, how they said it. One might not think that a large agency … Continue reading

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FDA’s OPDP Sends First Regulatory Letter of the Year Aimed at Rx Drug Promotion

Last week FDA’s Office of Prescription Drug Promotion issued its first regulatory action letter of the year. This was an Untitled Letter – a/k/a Notice of Violation Letter (NOV) – sent by the agency to Novartis in relation to promotional … 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’s OPDP Issues Two New Untitled Letters

While enforcement has been at a low ebb for quite some time with FDA’s Office of Prescription Drug Promotion (OPDP), this week took a different turn with the posting of two new untitled letters sent October 31. That brings the … Continue reading

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