ARTICLES BY KATE COOK
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![Clock Face Old]( "Bracing For March 23: FDA Issues Final Q&A On Transition Biologics")
Bracing For March 23: FDA Issues Final Q&A On Transition Biologics3/12/2020For 10 years, the date March 23, 2020 was circled in red on the FDA calendar. On that “transition date,” certain drugs FDA approved under the drug approval statute were “deemed” to have a biologics license instead of a New Drug Application approval. How soon will biosimilars see an impact?
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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.
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.