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.
Tag Archives: #AdComm
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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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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Virtual Reality – FDA and AdComms
Vaccination has been robust. Cities are opening up. Plans are underway for back-to-school. Travel is robust. Offices are cautiously re-opening. There are multiple hallmarks that, whatever the consequences, we are going back to normal. The age of COVID-19 will likely … Continue reading
Posted in Advisory Committee Prepapartion, COVID19, Current Affairs
Tagged #AdCom, #AdComm, COVID19
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“Can You Hear Me?” – The (Hopefully) Coming Transition from Virtual Meetings
Today, FDA published notice in the Federal Register of an upcoming meeting of the Arthritis Drugs Advisory Committee that will be held May 6. The meeting will be held virtually. Last year when the pandemic reality started setting in, like … Continue reading
Posted in Advisory Committee Prepapartion, Current Affairs
Tagged #AdCom, #AdComm, COVID19
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FDA to Hold Virtual AdComm
I don’t usually publish the scheduling of an AdComm with a blog posting. But this one merits one. With fewer than the usual minimum of fifteen days’ notice, FDA has scheduled an FDA Advisory Committee meeting of the Cardiovascular and … Continue reading
Posted in Advisory Committee Prepapartion, FDA Image, FDA Policy
Tagged #AdCom, #AdComm, #FDAAdvisoryCommittee
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