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
The FDA and You Tube? Use of New Media in Pharma!
Something slipped by me a few weeks ago. When the FDA gave the thumbs up for silicone breast implants on November 17, the press release was also accompanied by a video link. Is the FDA readying itself to enter the … Continue reading
Posted in FDA Policy, Marketing, Risk Management
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Kurtains for Ketek?
Yesterday’s Federal Register carried a notice for meeting on Ketek held by the Anti-Infective Drug Advisory Committee to be held jointly with the Drug Safety and Risk Management Committee. It will be held held on December 14, 2006, from 8 … Continue reading
Posted in Risk Management
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Look Back at MedWatch Alerts – Have Products Gotten Safer This Year?
When I began this blog back in February, I took a look at the increase in MedWatch alerts being issued by the FDA. Here is what I said: Since 2003, there has been a notable increase of 200% in output … Continue reading
Posted in FDA Policy, Risk Management
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Communications and Health Literacy
Related to yesterday’s observations regarding risk management, a key component of risk management is communications. The appropriate communication not only of risk, but of proper use, are essential. It is food for thought for the communications companies that provide support … Continue reading
Posted in Risk Management
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When Risk Management Manages Away Benefit
There are drugs out there with obvious risks. Thalidomide comes to mind. It is a drug that, invented a long time ago, was banned because of the serious risks attendant in taking it to unborn children. Yet, many years after … Continue reading
Posted in Risk Management
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