![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 1 of 1. This is the beginning of the thread.
Posted by HOK on June 18, 2003, at 13:38:35
Got a question for you guys...
The FDA has announced a Prescription Drug User Fee Act (PDUFA) date of Nov 30th for this new sleep drug, Estorra. From what I've read, PDUFA means that the pharm company submitting the NDA makes an agreement with the FDA to set aside funds from the pharm co's other drugs currently on the market so that they can hire more staff to expedite the process of reviewing the new drug proposal. What I don't get is what the PDUFA date means in terms of the approvability process. Is the PDUFA day (Nov 30th '03), the day the FDA has mandated as its own deadline for releasing a decision of approvability on the drug? Or does this date refer to something else in the timeline?
This is the end of the thread.
Psycho-Babble Medication | Extras | FAQ
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.org
Script revised: February 4, 2008
URL: http://www.dr-bob.org/cgi-bin/pb/mget.pl
Copyright 2006-17 Robert Hsiung.
Owned and operated by Dr. Bob LLC and not the University of Chicago.