FDA, Industry Reach Generic Drug Fee Agreement

The New York Times, Published August 16, 2011

U.S. regulators and generic drugmakers have reached a compromise agreement for a user-fee program that would require the companies to pay some $299 million in the first year to accelerate drug approvals.

The Food and Drug Administration has been in negotiations with the generic drug industry since February to establish a user-fee program similar to one in place for brand-name drugs and medical devices.