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Cross-Practice Team Authors Law360 Article on FDA’s Right to Try Act and Expanded Access Pathway

Practices: Health Care, Life Sciences, FDA Regulatory, Clinical Research, Digital Health, Health Privacy & Security

A cross-practice team co-authored a Dec. 18 article published in Law360 that provides insights on the Right to Try Act pathway that provides patients not eligible for clinical trial enrollment with ways to obtain investigational drugs or biologics for therapeutic use, and the “expanded access” or compassionate use provision that also grants access to investigational drugs.

Health care partner Mark Barnes (Boston), life sciences partner Greg Levine (Washington, D.C.), health care associate David Peloquin (Boston) and corporate practice associate Michael DiMaio (Boston) examine recent changes made by the U.S. Food and Drug Administration to the expanded access program to provide investigational therapies. The authors also analyze RTT and EA provisions impacting biopharmaceutical manufacturers.

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