ARTICLES BY KATE COOK
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![iStock-1136852280]( "Are You Prepared For Impending Changes To U.S. Biologics & Biosimilars Law?")
Are You Prepared For Impending Changes To U.S. Biologics & Biosimilars Law?1/16/2020Sponsors for insulins and other protein products originally submitted for premarket review under an NDA may be anticipating the arrival of March 23, 2020 with trepidation. On that date, the BPCIA requires that those NDA-approved products will be deemed to have a BLA approval instead of an NDA approval.
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![biosimilar industry]( "FDA Guidance On Premarket Pathways For Combo Products — What It Does (And Doesn’t) Say")
FDA Guidance On Premarket Pathways For Combo Products — What It Does (And Doesn’t) Say3/13/2019Last month, the FDA published the draft guidance “Principles of Premarket Pathways for Combination Products.” The document describes what a combination product is and how to interact with the FDA when developing a combination product, and it identifies some of the principles the agency uses in determining what type of premarket submission should be made.
Kate Cook
Kate Cook is executive VP of drug and biological products at Greenleaf Health, Inc. She joined Greenleaf after a long career at the FDA, including 15 years in the Office of Chief Counsel, five years in the Office of the Center Director at the FDA’s Center for Biologics Evaluation and Research, and one and a half as associate director for regulations and policy at the FDA’s Center for Devices and Radiological Health. You can contact her at kate.cook@greenleafhealthllc.com.