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: Complete Response Letters
Gilead Demonstrates the Folly of Formal Dispute Resolution
The FDA has a policy and a guidance for companies that want to pursue Formal Dispute Resolution (FDR) . This lays out the procedure by which companies can appeal an FDA decision about a product. It has been demonstrated many … Continue reading
Complete Response Letter Review for December 2008
"Complete Response Letter" is a kind of funny term. It implies finality when in fact, the outcome means that there is more to do. During December, a number of companies got their marching orders from the FDA. Here is a … Continue reading
Speaking of Complete Response Letters
Here I am – speaking of Complete Response Letters. What follows is a short tutorial on the communications aspects of CRLs. NOTE ADDED OCTOBER 19, 2010 – There has lately been a great deal of interest in this … Continue reading
FDA Requests Cephalon to Enhance Risk Mitigation Strategies Consistent with Company’s Recommendations
This is not exactly under the headline of news – a Complete Response Letter (CRL) was issued to Cephalon on the 15th of September for its supplemental New Drug Application (sNDA) for FENTORA(R) (fentanyl buccal tablet) [C-II] as a treatment … Continue reading
Posted in Complete Response Letters, Risk Management Comments Off on FDA Requests Cephalon to Enhance Risk Mitigation Strategies Consistent with Company’s Recommendations
Gilead Receives Complete Response Letter from FDA for Aztreonam Lysine for Inhalation, an Investigational Treatment for Cystic Fibrosis
Since Complete Response Letters (CRLs) have become the fashion for CDER after August 11, I have tried to make it a point to see how different companies respond to the receipt of such a letter in public communications. As I … Continue reading