About the Author
My name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in New York. For the past several years, I have been consulting with pharmaceutical and biologic companies that are engaged in the process of bringing new drugs to market. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.
Category Archives: FDA Policy
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
Posted in Advisory Committee Prepapartion, FDA Policy
Tagged #AdComm, #pharma, AdCom, AdComms
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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 … Continue reading
Posted in FDA Policy, Warning Letters
Tagged #FDA, #OPDP, #pharma
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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. This past June … Continue reading
Posted in FDA Policy, Warning Letters
Tagged #OPDP, #pharma, #Warning Letters
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FDA Announces New Study on Endorsements and DTC Television Ads
In today’s Federal Register, the agency has announced that the Office of Prescription Drug Promotion (OPDP) is adding a new study effort to its research portfolio. The category of that body of research that is currently underway includes a range … Continue reading
Posted in DTC Advertising, FDA Policy
Tagged #DTC, #OPDP, #pharma
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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
Posted in Advisory Committee Prepapartion, FDA Policy
Tagged #AdCom, #AdComm, #pharma
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