www.fdanews.com/articles/142959-sponsors-could-skirt-trial-requirements-under-senator-8217-s-8216-progressive-approval-8217

Sponsors Could Skirt Trial Requirements Under Senator’s ‘Progressive Approval’

January 5, 2012

Draft proposals from Sen. Kay Hagan (D-N.C.) and the Biotechnology Industry Organization (BIO) would allow the FDA to grant marketing authorizations before sponsors meet current clinical trial requirements.
Clinical Trials Advisor