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.
Category Archives: Risk Management
A Conversation with the FDA About the Nature of REMS
In 2007, the Food and Drug Administration Amendments Act (FDAAA) was signed into law by President Bush. The legislation contained a great deal of reform of FDA regulation over the pharmaceutical and biotech industries, one element of which was … Continue reading
Posted in FDA Policy, Risk Management
2 Comments
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
Returning a Product to Market After it is Tossed
The FDA announced on Friday that the drug Zelnorm, manufactured by Novartis, would be returning to market for the treatment of women with irritable bowel syndrome (IBS) for certain patients only. "These patients must meet strict criteria and have no … Continue reading
Posted in Drug Safety, Risk Management
1 Comment
Risky Business
Last week, the FDA announced the formation of a new Risk Communications Advisory Committee that will differ from the existing Drug Safety and Risk Management Advisory Committee, presumably by focusing solely on communication of risk. Yesterday and today, the FDA … Continue reading
Posted in Risk Management
Comments Off on Risky Business
Risk Management Workshop
The FDA is scheduled to announce today a Risk Management Workshop designed to discuss such programs and share information among key stekholders. Risk Management has been an increasing source of concentration in the post-COX-2 era. There were compounds prior to … Continue reading
Posted in Drug Safety, Risk Management
Comments Off on Risk Management Workshop