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: PDUFA
PDUFA IV Meeting Announcement
In today’s Federal Register, there is a whopping entry published from FDA regarding that publishes proposed recommendations for PDUFA IV that will cover years 2008-2012. Whopping refers to its length- 11 pages in PDF! It makes good reading if you … Continue reading
PDUFA Fees to Raise Money for Ad Reviews
And now, for a commercial break. At the precipice of the Congressional turnover, the FDA has reached a tentative agreement regarding the review by the agency of television commercials. According to the Wall Street Journal last week, pharmaceutical companies would … Continue reading
Posted in DTC Advertising, PDUFA
2 Comments
What Will the Next PDUFA Look Like?
There is an interesting conundrum developing. PDUFA – the legislation that allows for the collection of fees from the pharmaceutical industry to be applied to the FDA budget – is up for debate and reauthorization in 2007. The elections will … Continue reading
Posted in PDUFA, Pharma Industry Image
Comments Off on What Will the Next PDUFA Look Like?
A Question on Risk/Benefit Budgeting
It is Friday and I tend to allow myself a little wiggle room on Fridays to wander far and wide, topically. One of the reasons I’m really ready for Friday is that I attended the Pediatric Advisory Committee meeting this … Continue reading
Posted in FDA Policy, PDUFA
1 Comment