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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Legislative Tracking Tools
Monthly Archives: August 2008
Here is a new addition to the Eye on FDA YouTube channel going under the Investment Vids playlist from Morningstar on Biotech stocks to watch. Morningstar associate director of equity research Debbie Wang offers her take on possible takeout targets:
Posted in Finance Comments Off on For Investors
Weekly Roundup – 08/29/08
Yesterday I turned another year older and was so mesmerized by that fact that I was unable to write a posting – forgive me. Also, I’ve got that "end-of-August-I-don’t-want-to-go-back-to-school" feeling that I’ve never been able to shake in adult life. … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup – 08/29/08
FDA Issues New Complete Response Letter
Pursuant to my posting earlier today, by coincidence, Johnson & Johnson announced the receipt of a Complete Response Letter. It is worth noting that they provided no details about the contents of the letter, except to say that there were … Continue reading
Posted in Complete Response Letters Comments Off on FDA Issues New Complete Response Letter
Approvable Letters/Not Approvable Letters Replaced at CDER by Complete Response Letters – Why it isn’t Potato/Potahto
On August 11, the Center for Drug Evaluation and Research (CDER) put into force a new final rule on the way it respond to New Drug Applications (NDAs) that effectively did away with Approvable Letters and Not Approvable Letters in … Continue reading
Posted in FDA Policy 1 Comment