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FDA to Ensure Exocrine Pancreatic Insufficiency Drugs

10/26/2007

Federal Register Notice: FDA intends to continue to exercise enforcement discretion to ensure the continued availability of exocrine pancreatic insufficiency drug products after 4/28/08. The agency plans to exercise its enforcement discretion on unapproved pancreatic enzyme drug products until 4/28/10, if the manufacturers have investigational new drug applications on active status on or before 4/28/08, and have submitted NDAs on or before 4/28/09. To view this notice, click here.

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