Food and Drug Administration Mission Reform Act of 2011

Summary

Food and Drug Administration Mission Reform Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise the mission of the Food and Drug Administration (FDA) to include establishment of a regulatory system that: (1) advances medical innovation by incorporating modern scientific tools, standards, and approaches; (2) protects the public health and enables patients to access novel products while promoting economic growth, innovation, competitiveness, and job creation among the industries regulated by the FFDCA; (3) is based on the best available science; (4) allows for public participation and an open exchange of ideas; (5) promotes predictability, allows flexibility, and reduces uncertainty; (6) identifies and uses the most innovative and least burdensome tools for achieving regulatory ends; (7) ensures that regulations are accessible, consistent, transparent, written in plain language, and easy to understand; (8) measures, and seeks to improve, the actual results of regulatory requirements; and (9) incorporates a patient-focused benefit-risk framework that accounts for varying degrees of risk tolerance.

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3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 8 December 2011

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 8 December 2011

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• Introduced in Senate

  summary · EN · 8 December 2011

  Open at official source

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