Tag Archives: Drug Approvals

AdComm Drop-off in 2019 – FDA Consults Fewer Experts in 2019

Posted on November 13, 2019 by Mark Senak

The system of FDA Advisory Committees is in place so that when FDA needs advice – either on policy development, reviewing an issue with an already approved medicine, or regarding new drug approvals – the agency has a lot of … Continue reading →

Posted in Uncategorized | Tagged AdComms, Advisory Committees, Drug Approvals, FDA | Comments Off

Sorting it Out – FDA AdComm Review for 2018

Posted on February 21, 2019 by Mark Senak

In 2017, the Advisory Committees voted to recommend approval 71.4 percent of the time; in 2018 it was 66.6 percent. Continue reading →

Posted in Advisory Committee Prepapartion | Tagged AdComms, Drug Approvals, FDA, Pharma | 1 Comment

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.
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I am an authority on regulatory aspects of communications and medical products, with particular emphasis on pre-approval communications; strategist to help pharma and biotech companies prepare best case for advisory committee approval; and counselor in issues and crisis management. I am a frequent speaker on various aspects of same - drug development, promotion, reimbursement and new media in a highly regulated environment. Author of books, newspaper and magazine pieces related to drug marketing and promotion as well as HIV specialty pieces. And of course... blogger!
About This Blog

Eye on FDA is published by Mark Senak of FleishmanHillard's Washington, D.C. office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of FleishmanHillard or its clients.
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Tag Archives: Drug Approvals

AdComm Drop-off in 2019 – FDA Consults Fewer Experts in 2019

Sorting it Out – FDA AdComm Review for 2018

About the Author

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