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Regulatory Affairs

FDA Adds New AdComm to Address Genetic Metabolic Diseases

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, last year saw a marked increase …

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

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 content …

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The Year in AdComms – A Look Back at 2023

The Year in AdComms – A Look Back at 2023 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 …

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FDA’s OPDP Issues Two New Untitled Letters

FDA’s OPDP Issues Two New Untitled Letters 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 total …

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FDA Launching New Advisory Committee on Digital Health

FDA Launching New Advisory Committee on Digital Health 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 …

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What Happens When You Talk About Adherence in Promotional Communications?

What Happens When You Talk About Adherence in Promotional Communications? What Happens When You Talk About Adherence in Promotional Communications? FDA has announced that the Office of Prescription Drug Promotion (OPDP) is planning a study to evaluate the influence that statements made in a promotional communication about patient adherence to a medication may have on …

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Drug Approvals and FDA AdComms in 2023

Drug Approvals and FDA AdComms in 2023 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 – …

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FDA’s OPDP Issues Third Letter of 2023

FDA’s OPDP Issues Third Letter of 2023 FDA’s OPDP Issues Third Letter of 2023 For the second time this month and the third time this year, FDA’s OPDP has posted notice that it has taken an enforcement action. Last week, a Warning Letter was posted regarding a sales aid. This week it action came in …

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FDA’s OPDP Issues Second Regulatory Action Letter of 2023

FDA’s OPDP Issues Second Regulatory Action Letter of 2023 FDA’s OPDP Issues Second Regulatory Action Letter of 2023 In what has been a long period of relative low activity, FDA’s OPDP has taken the opportunity to remind us that low enforcement does not mean no enforcement when it comes to promotional speech by pharmaceutical companies. …

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