User fee increase of about 20% under discussion between FDA and industry.
This article was originally published in The Tan Sheet
Executive Summary
FDA/INDUSTRY USER FEE REAUTHORIZATION DISCUSSIONS FOCUSING ON 20% RAISE in user fees as the agency and brand-name pharmaceutical industry seek to reach an agreement in time for the opening of the 105th Congress. FDA is understood to have been seeking roughly a doubling of the fees in exchange for expanded services. The agency, however, could be willing to accept an increase of about 20% to cover a lesser package of commitments on the review process.