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

Posted in PDUFA | 1 Comment

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