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.
Monthly Archives: March 2008
Better Late than Never? FDA Oks Slower Approvals
As mentioned in yesterday’s post, the FDA has signaled that due to work burden, the agency will be allowing PDUFA dates to be missed… The RPM Report got the lowdown from John Jenkins, director of the Office of New Drugs … Continue reading
Posted in FDA Policy
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Turning Down the Pipeline on Biotechnology
On the Ides of March, Genetic Engineering and Biotechnology News (GEN) published an article by Ronald A. Rader, President of the Biotechnology Information Institute that provided an overview of the product approval rate focusing solely on biologics. For a long … Continue reading
Posted in Biologics
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Approvable Letter for MRSA Treatment
Basilea Pharmaceutica announced today that the FDA has issued an approvable letter for its first-in-class anti-MRSA agent cephalosporin for which company sought an indication to treat skin infections and diabetic foot infections. According to the company, prior to approval the … Continue reading
Posted in Approvable Letters
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Putting FDA Under the Congressional Microscope
Last week, the FDA offered testimony before the House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations regarding food safety delivered by Stephen F. Sundlof, DVM, PhD, Director at the Center for Food Safety and Applied Nutrition. It … Continue reading
Posted in Current Affairs
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American Health & Drug Benefits
I’ve been writing a column called FDA Watch for a new peer reviewed journal called American Health & Drug Benefits. The maiden issue came out in February and included an article by Newt Gingrich and Nancy Desmond called "Creating a … Continue reading
Posted in Useful Resources
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