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: Regulatory Communications
Social Media and Pharmaceutical Marketing
On several occasions in the past, I have posted here on the need for pharmaceutical companies to embrace new and social media, along with several suggestions for doing so. One of the perceived barriers to the involvement of pharmaceutical companies, … Continue reading
Posted in Marketing, Regulatory Communications, Social Media, Useful Resources
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Anatomy of a Consent Decree
Following yesterday’s posting about catching up, another thing that happened last week is that a Consent Decree was issued by the FDA. The company involved was Shelhigh, Inc., which produces implantable devices. First of all, what is a Consent Decree? … Continue reading
Tracking Approvable Letters
There are three general outcomes from submitting a new drug to the FDA for approval. First – approval, for which everyone hopes. Second non-approval, which is the obvious bad scenario. Third are approvable letters, issued by the FDA when they … Continue reading
Posted in Regulatory Communications
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Warning About Warnings!
As I mentioned in an earlier posting on February 24, the FDA has dramatically increased the issuance of MedWatch Alerts. Now the Baltimore Sun reports on the issue, which touches upon another matter discussed here – the relevance of FDA … Continue reading
Posted in FDA Policy, Regulatory Communications, Risk Management
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Lessons for a New Regulatory Era, Part 2
Risk management is an iterative process, as the FDA likes to say. There are a broad spectrum of activities that comprise efforts at managing risk. There is the product labeling and within that there is the Black Box Warning (see … Continue reading
Posted in Regulatory Communications
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