ARTICLES BY KATE COOK
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FDA Guidance On Premarket Pathways For Combo Products — What It Does (And Doesn’t) Say3/13/2019
Last month, the FDA published the draft guidance “Principles of Premarket Pathways for Combination Products.”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.
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