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
Regulation Cutting Impact on FDA and AdComms
During the campaign, candidate Donald Trump made several statements referring to the fact that he would be cutting regulation in this country by 70-80 percent. Since the election, that sentiment has been repeatedly affirmed. Now in office, this week he … Continue reading
Posted in Advisory Committee Prepapartion, FDA Policy
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Breakthrough Therapy Status, AdComms and Approvals
In recent years FDA has undertaken several means to facilitate the consideration of new drug applications by creating various mechanisms for expedited review for either new drugs or new indications for existing drugs. Prior to 2012, there had long been … Continue reading
Posted in Advisory Committee Prepapartion, FDA Policy
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AdComm Recommendations – How Often FDA Does Not Follow Them?
When an FDA Advisory Committee meets and deliberates whether or not the new drug application put before the agency should or should not be approved, they gather together and deliberate in a public forum often for hours. Prior to the … Continue reading
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Once and Future AdComms Affecting Drug Applications
One area of FDA activity that I like to track is in relation to advisory committees which I think provide us with something of a surrogate marker for the pace at which FDA is considering and approving new drugs. To … Continue reading
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Advisory Committee – Vacancies and Transparencies
The FDA has a total of 33 Advisory Committees, 17 of which are focused on Drugs and 5 of which are focused on blood, vaccines and other biologics. For our purposes today, we are going to focus on those dedicated … Continue reading
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