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
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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 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: Clinical Trials
Clinical Trials and Social Media – Part 1 in an Intermittent Series
Last week Brian Reid wrote an excellent piece on the Common Sense blog entitled “The 5 Consequences of the Lack of FDA Social Media Guidance“. He got off to a great start, but I actually think there are many more … Continue reading
Posted in Clinical Trials, Social Media
6 Comments
Adolor Corp. Gets Approvable Letter
Today Adolor Corp. announced receipt of an approvable letter from the FDA requesting 12-month safety data that includes an analysis of any cardiovascular related adverse events. The application was for Entereg, indicated for the management of postoperative ileus.
Posted in Clinical Trials
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Adaptive Clinical Trials Workshop – An Opportunity Gone South
Back in July when Dr. Scott Gottlieb made a speech before the American Medical Association and made a lengthy reference to a November workshop in which FDA would participate regarding adaptive clinical trials, there was a great deal of anticipation … Continue reading
Posted in Clinical Trials
1 Comment
Antibiotics and Clinical Trials
What happens when the FDA decides on new policies during the course of a clinical trial? Last week, Replidyne and Forest Laboratories reported that the FDA issued a non-approvable letter for Faropenem, an antibiotic. The FDA wanted further clinical studies … Continue reading
Posted in Clinical Trials
1 Comment
Is the Adaptive Clinical Trials Workshop a Private Affair?
One might ask oneself why, if an important conference in which there is a high level of interest is just a few weeks away, have details not been announced. The answer may be that most of us assumed that the … Continue reading
Posted in Clinical Trials
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