Patient-Focused Impact Assessment Act of 2016

Summary

Patient-Focused Impact Assessment Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to require the package of information published by the Food and Drug Administration (FDA) upon approval of a new drug to include documentation of efforts to assess patient engagement. This documentation must include identification of patient-focused drug development tools and an explanation of whether certain information was reviewed or examined, including patient preferences and patient-reported or caregiver-reported outcomes. The FDA must annually summarize the data collected in this documentation. The FDA must publish guidance on collaboration between patients, advocacy organizations, and industry for the purposes of developing patient-focused drug development tools and obtaining patient perspectives on medical products under development.

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Documents

6 official files

• Reported to Senate (text)

  Reported to Senate · EN · 5 April 2016

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• Reported to Senate (PDF)

  Reported to Senate · EN · 5 April 2016

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• Reported to Senate with amendment(s)

  summary · EN · 5 April 2016

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• Introduced in Senate (text)

  Introduced in Senate · EN · 17 June 2015

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 17 June 2015

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• Introduced in Senate

  summary · EN · 17 June 2015

  Open at official source

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