January 16, 2007
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 →
November 28, 2006
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 →
April 12, 2006
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 →
March 24, 2006
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 →