Ensuring Timely Access to Generics Act of 2019

Summary

Ensuring Timely Access to Generics Act of 2019 This bill requires the Food and Drug Administration (FDA) to consider certain factors in determining whether a petition is submitted for the primary purpose of delaying the approval of a drug application. The FDA must (1) publish a list of petitions that were submitted with an intent to delay, and (2) establish procedures to refer such petitions to the Federal Trade Commission. The FDA may establish a timeline for submitting petitions.

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3 official files

• Introduced in House (text)

  Introduced in House · EN · 1 May 2019

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• Introduced in House (PDF)

  Introduced in House · EN · 1 May 2019

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• Introduced in House

  summary · EN · 1 May 2019

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