Pre-approval Access Webinar
The Reagan-Udall Foundation for the FDA's Executive Director, June Wasser, was a presenter on a June 6th webinar sponsored by Johnson & Johnson and NYU Langone Health. She explained how patients use the Foundation's Expanded Access Navigator. The Navigator was launched in June 2017 and serves as a clearinghouse of neutral information on the process physicians use to request expanded access to investigational therapies under development by biopharmaceutical companies. In addition to educational material, the Navigator offers a Company Directory for patients and physicians to find the expanded access policies and clinical trial record numbers of participating companies. The June webinar also featured a discussion of updates to clinicaltrials.gov by its Associate Director, Rebecca Williams, Pharm.D., MPH.
You can watch the recorded webinar, here's the link.