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
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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Big Decisions – Reviewing FDA Advisory Committee Outcomes Since 2020
In January we took a look at FDA Advisory Committees (AdComms) – FDA AdComms – When the Going Gets Tough – noting, among other things that there had not only been fewer meetings but also that it appeared that the … Continue reading
Posted in Advisory Committee Prepapartion
Tagged AdCom, AdComm, AdComms, Drug Approvals, Pharma
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When the Going Gets Tough – FDA AdComms in 2022
Through its Human Drugs Advisory Committee process FDA has a vast array of outside experts to consult on matters related to product approval as well as questions about policy or safety issues concerning approved products. The mechanism provides an open … Continue reading
Posted in Advisory Committee Prepapartion
Tagged #AdCom, #AdComm, #FDA, #pharma
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FDA Advisory Committee Review of 2021
FDA has scheduled the first advisory committee meetings of 2022. One meeting of the Oncologic Drugs Advisory Committee is set for February 10 to discuss a new application for the proposed treatment of Non-Small Cell Lung Cancer (NSCLC. And a … Continue reading
Posted in Advisory Committee Prepapartion
Tagged AdCom, AdComm
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AdComms – Is FDA Getting Less Advice?
As more drugs are being approved, is FDA getting less advice than in the past? FDA maintains a vast network of outside advisors to provide input and counsel to the agency related to decisions on policy as well as product … Continue reading
Posted in Advisory Committee Prepapartion, FDA Image, FDA Policy
Tagged #AdCom, #AdComm, #pharma
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