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: September 2007
Weekly Roundup – 9-28-07
The week is at a close. So is September. And, a week’s vacation for me at Cape Hatteras also comes to an end. It was nice, but I’ve had to rely on dial-up, which has made posting to the blog … Continue reading
Posted in Weekly Roundup
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Another Approvable Letter Issued – Alcon for Retaane
An approvable letter was issued by the FDA to Alcon for Retaane 15 mg for the treatment of wet-aged macular degeneration (AMD). Approvable letters are issued when the FDA acknowledges that it is inclined to approval given certain conditions to … Continue reading
Posted in Uncategorized
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New DTC Oversight Powers Given FDA – Show Me the Money!
I was fascinated to read the RPM Report analysis of the new system that will emerge when the new FDA bill is signed into law. A new user fee program for review of DTC ads will exist that allows the … Continue reading
Posted in DTC Advertising, FDA Policy, Legislation, Marketing
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Advisory Committee – Conflicts of Interest – FDA Self Reform?
As mentioned last week, compromise legislation passed that is bringing a 5-year extension of PDUFA is also bringing with it a codification on reducing real or perceived conflict of interest rules for members of FDA advisory committees. The legislation sets … Continue reading
Posted in FDA Image, FDA Policy
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PSAs and YouTube – Another Installment on Social Media
I have written several postings in the past on uses of social media by pharmaceuticals. Just last week, I had a posting on Fard Johnmar’s excellent White Paper on the legal aspects of social media by pharmaceuticals. One idea that … Continue reading
Posted in Marketing, Social Media
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