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. The table below includes a consolidated annual summary report of Right to Try Act use during May 30, 2018 through December 31, 2022.
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 |