About the AuthorMy 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.
My ProfileI 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 New York 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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Category Archives: PDUFA
What is PDUFA?
I used to have a much beloved co-worker who was not in healthcare, but upon hearing the term "PDUFA" – standing for the Prescription Drug User Fee Act – for the first time during a meeting, shouted out "What the … Continue reading
Posted in PDUFA, Tutorial 2 Comments
Hurry Up and Wait – Delaying Priority Reviews
Earlier this year the FDA Director of the Office of New Drugs John Jenkins indicated that the agency would have a decreased ability to meet PDUFA dates, saying that the agency was short-staffed. Congress has also been investigating the use … Continue reading
Posted in PDUFA Comments Off on Hurry Up and Wait – Delaying Priority Reviews
Leaving PDUFA Alone
PDUFA IV, as has been noted here many times, is up for passage in the Congress. For those new to it, PDUFA is the Prescription Drug Users Fee Act which, if authorized, will provide a majority of funding for FDA … Continue reading
Posted in Legislation, PDUFA Comments Off on Leaving PDUFA Alone
DDMAC Enforcement Down – PDUFA Dollars Up – What is Wrong with that Formula?
As we are in the midst of approval for PDUFA IV, there has been a lot of talk from the FDA about the need for increased funds to bring greater focus on drug safety and even monitoring of marketing activities. … Continue reading
Posted in FDA Image, PDUFA, Warning Letters 1 Comment
Warning Letter Volume on the Decline
The very day after posting about the upcoming FDA meeting on PDUFA IV, I was getting ready to check out the Warning Letters for the 4th Quarter when I decided to look back on the DDMAC issued letters going back … Continue reading
Posted in PDUFA, Warning Letters 1 Comment