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.
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Next round of biomedical innovation legislation provides opportunity to require insurance reimbursement of investigational drugs and related medical services, as well as new incentives for small biotech companies to offer expanded access programs, stakeholders say.
US FDA Commissioner suggests Congress may need to explore incentives for drugmakers to make investigational products available in the pre-approval phase.
FDA must still determine internal procedures for receiving annual reports and handling adverse events through the controversial pathway that encourages access to unapproved therapies.