US FDA Right To Try Policy: For Now, Defer Questions To Sponsors, Bill Text
Agency tells staff that it should refer patient questions about the law to the drug sponsor, while sponsors should be told to read the statute if they inquire about it.
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For now, FDA is using a case-by-case approach for reviewing and approving expanded access applications asking for off-label uses.
Gottlieb: Lack Of Compromise On Right-To-Try Bill Is 'Interesting Lesson In Politics' For Stakeholders
In interview with the Pink Sheet, former US FDA commissioner Scott Gottlieb said that opposition to the modified House version of the right-to-try legislation ultimately led to the less favorable Senate bill becoming law.
CBER director said unlicensed stem cell clinics often report adverse events not made public, which is a concern under Right To Try.