Natalie Watson

Natalie Watson

McCarter & English, LLP

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FDA Issues Draft Guidance on Demonstrating Interchangeability Under the BPCIA

On January 17, 2017, the Food and Drug Administration (FDA) issued its long-awaited draft guidance on licensure as an interchangeable biological product approved under the Biologics Price Competition and Innovation Act of...more

2/6/2017  /  Biologics , Biosimilars , BPCIA , Draft Guidance , Food and Drug Administration (FDA) , Licensing Rules , Medical Licensure Compact , PHSA , Public Comment , Scientific Evidence
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