WASHINGTON - Negotiators from the Biotechnology Industry Organization, Pharmaceutical Manufacturers and Researchers Association and the FDA failed to meet the agency's goal of agreeing on terms of a new Prescription Drug User Fee Act (PDUFA) by Dec. 20. The negotiations, which the FDA wanted to wrap up by last Friday, now must resume in January.

FDA set the deadline because it wants a month to integrate the financial terms of the proposed agreement into a budget that it must submit to the White House Office of Management and Budget in early January.