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FDA Reauthorization Act.pdf

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Preview of FDA Reauthorization Act
🔗 Source: congress.gov
📊 Size: 425 KB
📄 Pages: 86 pages
⬇️ Downloads: 76

Summary

The FDA Reauthorization Act of 2017 revises and extends user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products. The act consists of nine titles, covering fees relating to drugs, devices, generic drugs, biosimilar biological products, pediatric drugs and devices, reauthorizations and improvements related to drugs, device inspection and regulatory improvements, improving generic drug access, and additional provisions. It amends the Federal Food, Drug, and Cosmetic Act to expedite the drug development process and review of human drug applications, including postmarket drug safety activities. The act also establishes fees for prescription drug applications, program fees for prescription drug products, and reauthorizes various programs, such as the orphan grants program and the critical path public-private partnerships.

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Description

The FDA Reauthorization Act of 2017 revises and extends user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological...

Technical Information

  • File Format: PDF
  • File Size: 425 KB
  • Pages: 86
  • Language: EN
  • Total Downloads: 76
  • Last Updated: 1 week ago

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