FDA Reauthorization Act of 2017

Summary

FDA Reauthorization Act of 2017 Prescription Drug User Fee Amendments of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to extend through FY2022 and revise Food and Drug Administration (FDA) user fees for new drug applications. User fees are eliminated for supplements to new drug applications and drug manufacturing facilities. Medical Device User Fee Amendments of 2017 The bill extends through FY2022 and revises FDA user fees for medical devices. A user fee is established for requests to classify devices that are not substantially equivalent to marketed devices. The FDA is no longer granted the discretion to waive or reduce fees in the interest of public health. The FDA must establish a pilot program to accredit testing laboratories to determine whether medical devices conform to performance standards. The bill revises the types of medical devices that the FDA may accredit third parties to review. Generic Drug User Fee Amendments of 2017 The bill extends through FY2022 and revises FDA user fees for generic drugs. User fees are eliminated for supplements to generic drug applications. An annual fee is assessed on holders of approved generic drug applications. Biosimilar User Fee Amendments of 2017 The bill extends through FY2022 and revises FDA user fees for biosimilars. (Biosimilars are biological products approved by the FDA based on their similarity to an already-approved biological product.) User fees are eliminated for supplements to biosimilar applications and biosimilar manufacturing facilities. An annual fee is assessed on holders of approved applications for biosimilars. The bill sets the annual amount of revenue that must be generated by fees. The bill extends through FY2022 programs and policies including Critical Path Public-Private Partnerships and support for development of medical products for rare conditions.

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Documents

6 official files

• Reported to Senate (text)

  Reported to Senate · EN · 11 May 2017

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• Reported to Senate (PDF)

  Reported to Senate · EN · 11 May 2017

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• Reported to Senate with amendment(s)

  summary · EN · 11 May 2017

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• Introduced in Senate (text)

  Introduced in Senate · EN · 25 April 2017

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 25 April 2017

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• Introduced in Senate

  summary · EN · 25 April 2017

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