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.Stay Connected
My Profile
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 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.
Posts by Date
Twitter List
Legislative Tracking Tools
Monthly Archives: June 2008
FDA Postings on YouTube
Today, the FDA posted a number of videos on YouTube today. It is worth noting that the agency is utilizing YouTube to educate patients. Right now, the FDA has only 61 subscribers and has had a YouTube account since … Continue reading
Posted in New and Social Media
Comments Off on FDA Postings on YouTube
New Media and Pharmaceutical Public Affairs
This week, I produced a draft of a paper that overviews the use of new and social media in public affairs. I was fascinated to find that not only are several members of Congress now twittering, the Clerk of the … Continue reading
Posted in New and Social Media
Comments Off on New Media and Pharmaceutical Public Affairs
A Guide to the Senate Elections
As we breathe a sigh of relief that the primaries are all finished, and the nominees identified, it is important to take note of the way the character of the election cycle as seen from various perspectives. It is, after … Continue reading
Posted in Legislation
Comments Off on A Guide to the Senate Elections
Approvable Letter Issued to Eurand
Eurand Pharmaceuticals announced last week that the company had received an approvable letter from the FDA for its NDA for EUR-1008 (pancrealipase capsules) for the treatment of exocrine pancreatic insufficiency (EPI). The company did not state the FDA’s reasoning for … Continue reading
Posted in Approvable Letters
Comments Off on Approvable Letter Issued to Eurand
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