Right-To-Try Bill Heads To White House, Putting Firms In Driver's Seat
Executive Summary
Proponent says companies ready to use new expanded access pathway that US FDA will have essentially no involvement in.
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Executive Privilege: How Giving Trump Special Access To Experimental COVID Treatment Could Backfire
Trump receives Regeneron’s experimental antibody under FDA’s expanded access program, Gilead’s remdesivir and dexamethasone. The president’s treatment choices could influence clinical trials of all COVID-19 medicines and even trial recruitment for other diseases, experts said.
Passive Adverse Event Approach Is Key Facet Of US FDA's Right-To-Try Rule
Sponsors will have little obligation to conduct due diligence of adverse events experienced with right-to-try drug use under a proposed FDA rule, leading critics to once again raise safety concerns with the pathway for accessing experimental medicines. The agency will not help patients or companies determine whether drugs qualify for right-to-try.