Monday, January 20, 1997
WASHINGTON - User fees for FDA reviews and manufacturing inspections will increase about 20 percent if Congress adopts a proposal that has been negotiated between industry representatives and FDA to reauthorize the Prescription Drug User Fee Act (PDUFA). In return, sponsors would get quicker reviews, a more consistent and predictable regulatory process, meeting deadlines and dispute resolution, and cost savings from paperless submissions.
Biotechnology Industry Organization President Carl Feldbaum said FDA, BIO and the Pharmaceutical Research and Manufacturers of America (PhRMA) have agreed on terms of a new version of PDUFA. A meeting is scheduled this week with Deputy Commissioner for Operations Michael Friedman to formally conclude the negotiations