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Zdrowie i gospodarka · 28/04/2004

FDA Classifies Exocrine Pancreatic Insufficiency Drug Products as New Drugs, Sets Conditions for Continued Marketing

The FDA is requiring manufacturers of exocrine pancreatic insufficiency drug products to submit new drug applications to continue marketing these products, while allowing a 4-year grace period for prescription products deemed medically necessary.

Source: Federal Register — Food and Drug AdministrationOpen original release →