A Critical Test for FDA's Critical Path Initiative
This article was originally published in RPM Report
FDA wants to reverse the deline in NDA approvals; the agency may have a key ally at a new center in Arizona.
You may also be interested in...
Crawford’s time as permanent FDA commissioner lasted less than three months and ended in scandal, but with that stint and his longer stretches as acting commissioner, he oversaw the agency through several historic moments that continue to influence the current regulatory environment.
After six months on the job, Carolyn Compton, the institute’s new chief executive, has overhauled the funding rules to allow fees from big pharma to cover overhead as government funding dries up. Successor to founder Raymond Woosley, who retired last year, Compton shares her vision for securing the institute’s finances for the future amid tough economic times.
FDA is joining in the push for new tuberculosis treatments, with Commissioner Hamburg lending support for a renewed development effort. The challenge is to translate podium appearances into changes that will make for a more attractive development pathway. The primary goal is to find a way to study multi-drug regimens, including regimens with more than one investigational compound. FDA is engaging on that thorny regulatory issue.