Insights On Right To Try Act And 'Expanded Access' Concerns
Law360 (December 18, 2018, 11:12 AM EST) -- In an earlier article authored by Ropes & Gray LLP attorneys, we summarized the implications of the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, or the RTT. President Donald Trump signed the RTT into law in May 2018 to provide patients who are not eligible for enrollment in a clinical trial with a pathway to obtain investigational drugs or biologics for therapeutic use. There is an existing expanded access, or EA, pathway, however, referred to colloquially as “compassionate use,” that also provides access to investigational products for therapeutic use. Generally, under both pathways,...
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