CREATES Act of 2019

Summary

Creating and Restoring Equal Access to Equivalent Samples Act of 2019 or the CREATES Act of 2019 This bill generally allows the developer of a drug or biological product, such as a generic or biosimilar version of a drug, to bring a civil action against the license holder of an approved medication if the holder refuses to make available sufficient quantities of the approved medication for the developer's testing. The bill also establishes affirmative defenses to such a civil action. In addition, the bill authorizes drug manufacturers seeking Food and Drug Administration approval for a generic drug to use alternative methods to develop elements assure safe use of a drug.

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Documents

3 official files

• Placed on Calendar Senate (text)

  Placed on Calendar Senate · EN · 6 February 2019

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• Placed on Calendar Senate (PDF)

  Placed on Calendar Senate · EN · 6 February 2019

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• Introduced in Senate

  summary · EN · 5 February 2019

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