Will Tenbarge

Will Tenbarge

Hogan Lovells

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Key considerations for responding to a CREATES Act request

Enacted in December 2019 as part of the Further Consolidated Appropriations Act of 2020, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (21 USC 355-2) addresses concerns that some brand...more

1/29/2024  /  Biosimilars , CREATE Act , Food and Drug Administration (FDA) , Generic Drugs , Pharmaceutical Industry
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