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.
You may also be interested in...
Updated guidance on expanded access program clarifies that sponsors do not risk enforcement for off-label promotion if they post investigational drug expanded access policies, although that fear already may have subsided.
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.