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PDUFA 101

By Andrew Powaleny  |    September 3, 2015
With Prescription Drug User Fee Act (PDUFA) VI FDA-Industry negotiations about to commence, we’re taking a look at what PDUFA is, how it works, and explaining why it has been a tremendous success...   Read More

The drug development and approval process is about much more than the final “okay”

By Tina Stow  |    August 24, 2015
A recent Forbes story not only presents an oddly limited look at the U.S.’s drug development process, it also sends a misleading message to America’s patients and health care professionals. “The...   Read More

PDUFA: Still a weird word worth knowing

By Stephanie Fischer  |    January 24, 2013
As my predecessor noted, PDUFA is indeed a weird word worth knowing. The Prescription Drug User Fee Act (PDUFA), reauthorized last year as part of the Food and Drug Administration (FDA) Safety and...   Read More

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