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When did the U.S. Food & Drug Administration (FDA) require that pancreatic enzyme products (PEPs) receive formal FDA-approval?

April 26, 2017Administration drug enzyme fda food pancreatic peps products require

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When did the U.S. Food & Drug Administration (FDA) require that pancreatic enzyme products (PEPs) receive formal FDA-approval?

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• In April 2004, the FDA published a Federal Register Notice requiring that all PEP manufacturers had four years to obtain approval. In October 2007, FDA extended the deadline for approval to April 28, 2010.