ARTICLE | Politics, Policy & Law
Progressive thinking for FDA
BIO, NVCA propose progressive approval of drugs, FDA advisory committee reform
June 27, 2011 7:00 AM UTC
A few weeks after finishing negotiations with FDA over a PDUFA V deal that seeks to tweak drug oversight with changes to the review process, BIO now plans to propose sweeping changes to the U.S. regulatory system.
This week the biotech trade association will call for the creation of a provisional approval pathway, mandates for FDA to promote medical innovation, and a complete restructuring of the agency's relationships with Congress and the White House...