FDA proposes new rule on reporting requirements to support Right to Try

On July 23, the U.S. Food and Drug Administration (FDA) announced a new proposed rule that would require sponsors and manufacturers who provide an ‘‘eligible investigational drug’’ under the Right to Try Act to submit an annual summary of such use to FDA.

The Right to Try Act (RTT), or the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2017, provides a pathway for patients who have been diagnosed with life-threatening diseases or conditions who have tried all approved treatment options and who are unable to participate in a clinical trial, to access certain unapproved treatments.

RTT was enacted in May 2018 but to date it is not known how many RTT requests have been made or the number of patients who have been treated under the program.

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