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                Learn About Expanded Access and Other Treatment Options

Learn About Expanded Access and Other Treatment Options

                        Right to Try
          Understanding Investigational Drugs
          Right to Try Annual Reporting Summary


                        Understanding Unapproved Use of Approved Drugs "Off Label" Home
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          Learn About Expanded Access and Other Treatment Options
          Right to Try Annual Reporting SummaryLearn About Expanded Access and Other Treatment Options Right to Try Annual Reporting Summary
  
  	
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    PrintFDA 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

                                                                                  Content current as of:
      09/29/2023Learn About Expanded Access and Other Treatment Options

          
                        Right to Try
          Understanding Investigational Drugs
          Right to Try Annual Reporting Summary


                        Understanding Unapproved Use of Approved Drugs "Off Label"
 
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