Expanded Access: FDA’s New Regulatory Process How Compassionate Use Fits into Proposed Reforms

October 13, 2016

2001 K Street N.W., Suite 400
Washington, DC
McGuireWoods Partner Kate Hardey and Senior Counsel Brian Malkin moderated sessions at this 1/ 2 day top-level briefings from patient advocacy groups. This question-and-answer briefing covered regulations and guidance and gave attendees an inside peek on what’s ahead in 2017. Attendees also had the opportunity to have an open discussion with Richard Klein, FDA Patient Liaison Program Director, as well as a host of other nationally recognized speakers on FDA’s expanded access programs, industry experts and representatives from patient advocacy groups.

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