To direct the Secretary of Health and Human Services to open a public docket for the submission of public comments regarding factors that should be taken into consideration when reviewing a proposed modification to an approved risk evaluation and mitigation strategy, and for other purposes.

Summary

This bill requires the Food and Drug Administration to solicit public comment on factors that should be taken into account when considering proposed modifications to approved risk evaluation and mitigation strategies for drugs. The Government Accountability Office must report on the number of proposed modifications that have been granted and the related effects on patient access or provider administration with respect to such drugs.

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3 official files

• Introduced in House (text)

  Introduced in House · EN · 3 May 2022

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• Introduced in House (PDF)

  Introduced in House · EN · 3 May 2022

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• Introduced in House

  summary · EN · 3 May 2022

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