FDA Unveils New Fee Proposal For Drug Reviews

Law360, New York (September 1, 2011, 8:23 PM EDT) -- The U.S. Food and Drug Administration published a draft proposal Thursday promising it would review new drugs more quickly under a reauthorized Prescription Drug User Fee Act in exchange for a reported 6 percent increase in fees on drugmakers.

An FDA spokeswoman said the proposal would boost drugmakers' user fees by about 6 percent, which would create an estimated additional $40.4 million in revenue for fiscal year 2012, The Associated Press reported.

Enacted in 1992, the PDUFA allows the FDA to charge fees to manufacturers of...
To view the full article, register now.
Law360 Pro Say Podcast
Check out Law360's new podcast, Pro Say, which offers a weekly recap of both the biggest stories and hidden gems from the world of law.