Guidance for Industry: Exocrine Pancreatic Insufficiency Drug Products-Submitting New Drug Applications; Withdrawal of Guidance

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The Food and Drug Administration (FDA or Agency) is announcing the withdrawal of a guidance for industry entitled "Exocrine Pancreatic Insufficiency Drug Products--Submitting NDAs," which was issued in 2006. The guidance set forth the Agency's thinking on data and information that may support a new drug application (NDA) for a proposed pancreatic enzyme product (PEP) that contains pancreatin or pancrelipase and is intended for the treatment of exocrine pancreatic insufficiency (EPI). FDA is withdrawing the guidance because an NDA for such a product may not be submitted after March 23, 2020. Sponsors interested in submitting a biologics license application (BLA) for a proposed PEP should contact the Agency with any questions.