IND regs offer more ways to expand access - and to charge patients for it
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Pharma firms will see few policy changes following the publication of FDA's final regulations on expanded access to investigational medicine, but the revisions could nevertheless mean more patients and doctors will come knocking on their doors asking for experimental drugs. A companion reg also gives companies more options for changing patients for experimental products - if they are willing to open their books up to FDA (1"The Pink Sheet," Aug. 17, 2009)