Guidance for Industry on Exocrine Pancreatic Insufficiency Drug Products-Submitting New Drug Applications; Availability

الملخص

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Exocrine Pancreatic Insufficiency Drug Products--Submitting NDAs." This guidance is intended to assist manufacturers of exocrine pancreatic insufficiency drug products in preparing and submitting documentation to meet new drug application (NDA) requirements for the drug products.