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.
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 BlogEye 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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Category Archives: Clinical Trials
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. Share this:
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
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
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