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Right to Try Annual Reporting Summary

FDA receives annual summaries from manufacturers or sponsors on eligible investigational drugs used under the Right to Try Act, which was signed into law on May 30, 2018. The table below includes a consolidated annual summary report of Right to Try Act use. 

The final rule specifying the deadline and content for submission of an annual summary of investigational drugs supplied under the Right to Try Act was published in the Federal Register in September 2022, effective November 2022. Data from the first reporting period covers May 30, 2018 through December 31, 2022. Data in subsequent years is listed by calendar year, January 1 through December 31. 

Reporting Period 
(Calendar Year)
Number of eligible drugs and biologics for which clinical outcomes data were used in determining the safety of the investigational drug
(used in accordance with subsection (c)(1)(A))
Number of eligible drugs and biologics for which the sponsor requested use of the clinical outcomes data
(used in accordance with subsection (c)(1)(B))
Number of eligible drugs and biologics for which clinical outcomes data were not used in the review of an application to market a new drug or to license a new biologic product
(not used in the review of an application under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262])
2018-2022 0 0 12
2023 0 0 4

 

 
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