Category Archives: PDUFA

What is PDUFA?

Posted on July 26, 2010 by Mark Senak

 I used to have a much beloved co-worker who was not in healthcare, but upon hearing the term "PDUFA" – standing for the Prescription Drug User Fee Act – for the first time during a meeting, shouted out "What the … Continue reading →

Posted in PDUFA, Tutorial | 2 Comments

Hurry Up and Wait – Delaying Priority Reviews

Posted on June 23, 2008 by Mark Senak

Earlier this year the FDA Director of the Office of New Drugs John Jenkins indicated that the agency would have a decreased ability to meet PDUFA dates, saying that the agency was short-staffed.  Congress has also been investigating the use … Continue reading →

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Leaving PDUFA Alone

Posted on April 10, 2007 by Mark Senak

PDUFA IV, as has been noted here many times, is up for passage in the Congress.  For those new to it, PDUFA is the Prescription Drug Users Fee Act which, if authorized, will provide a majority of funding for FDA … Continue reading →

Posted in Legislation, PDUFA | Comments Off on Leaving PDUFA Alone

DDMAC Enforcement Down – PDUFA Dollars Up – What is Wrong with that Formula?

Posted on April 4, 2007 by Mark Senak

As we are in the midst of approval for PDUFA IV, there has been a lot of talk from the FDA about the need for increased funds to bring greater focus on drug safety and even monitoring of marketing activities. … Continue reading →

Posted in FDA Image, PDUFA, Warning Letters | 1 Comment

Warning Letter Volume on the Decline

Posted on January 17, 2007 by Mark Senak

The very day after posting about the upcoming FDA meeting on PDUFA IV, I was getting ready to check out the Warning Letters for the 4th Quarter when I decided to look back on the DDMAC issued letters going back … Continue reading →

Posted in PDUFA, Warning Letters | 1 Comment