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: Advisory Committee Prepapartion
FDA Adds a New AdComm for Patients
This week FDA published a Federal Register announcement stating that the agency was establishing a new Patient Engagement Advisory Committee designed to provide counsel to the Commissioner on issues related to medical devices. The agency said that the scope is … Continue reading
Posted in Advisory Committee Prepapartion, FDA Policy
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Live Streaming – Game Changer for AdComms and Beyond?
This week there was a lot of talk about last week and the meeting of the American Society of Clinical Oncology annual meeting ASCO 15, which was the 51st annual meeting of the society held May 29 – June 2 … Continue reading
Posted in Advisory Committee Prepapartion, New and Social Media, Social Media
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Advisory Committee Track Records
Needless to say, every time a product goes before an FDA Advisory Committee (AdComm), there are circumstances that make the deliberations that occur during that meeting a unique experience. A specific investigative compound being studied for a specific indication with … Continue reading
Posted in Advisory Committee Prepapartion
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AdComms for Last Quarter of 2014
It is hard to believe it, but we have entered the final quarter of 2014. I thought it a good time to revisit the upcoming AdComm schedule for those AdComm meetings that affect drugs or devices. Prior postings that provided … Continue reading
Posted in Advisory Committee Prepapartion
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Upcoming AdComms By Subject Matter
In February and in April I posted a listing of upcoming advisory committees by subject matter and people seemed to like this way of looking at it, so I try to repeat it every so often. Today is every so … Continue reading
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