Category Archives: PDUFA

What is PDUFA?

 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

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

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

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

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

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