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: October 2007
Draft Guidance on Conflict of Interest for Advisory Committees Issued by FDA
The Food and Drug Administration today is scheduled to publish a Draft Guidance in the Federal Register entitled Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and DRug Administration Staff: Public Availability of Advisory … Continue reading
Posted in FDA Policy
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Joe Biden – Where the Candidates Stand, Part I in a Series
There are 65 days left to the Iowa Caucus. As I mentioned last week, I intend to profile the healthcare positions of each of the candidates as those positions might affect the workings of the FDA and the pharmaceutical market. … Continue reading
Posted in Current Affairs
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The New Prescription Drug User Fee Program for DTC for Drug and Bio Products
Tomorrow, the FDA will be publishing a Notice entitled the "User Fee Program for Advisory Review of Direct-to-Consumer Television Advertisements for Prescription Drug and Biologic Products; Request for Notification of Participation and nUmber of Advertisements for Review" – A MOUTHFUL! … Continue reading
Posted in FDA Policy
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Another OTC Attempt for Mevacor
In July of 2000, two companies tried to take statins from RX to OTC. The first was Bristol Myers Squibb attempting to switch Pravachol and the other was Merck trying to switch Mevacor. Today, there is a Federal Register notice … Continue reading
Posted in OTC Switches
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Where Do the Candidates Stand?
Since 2000, more than 7 million Americans have entered the ranks of the uninsured. Today, healthcare, and its related elements, are the number two concern among voters. We have no shortage of candidates, though the ranks grew smaller last week … Continue reading
Posted in Current Affairs
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