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Posting Preapproval Access Policies Could Help Prevent ‘Blame And Shame’ Under Right To Try

Executive Summary

Many biopharmas have not publicly posted their policies for evaluating and responding to expanded access requests as required under the 21st Century Cures Act. Putting this information out will help set patient community expectations, but will not viewed by US FDA as off-label promotion, experts say at BIO annual meeting.

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