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.
Daily Archives: March 18, 2008
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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