Simplifying the Generic Drug Application Process Act

Summary

Simplifying the Generic Drug Application Process Act This bill removes a requirement for a generic drug maker to, in some instances, petition the Food and Drug Administration (FDA) before seeking market approval for a generic drug. Currently, if an applicant wishes to submit an abbreviated application (i.e., the type of application typically used to get market approval for a generic drug) for a drug that has a different dosage form or strength from an already-approved drug, the applicant must first petition the FDA for permission to submit the application. Under this bill, an applicant is no longer required to petition the FDA for permission in these instances.

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3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 29 April 2021

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 29 April 2021

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• Introduced in Senate

  summary · EN · 29 April 2021

  Open at official source

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