Бизнес · 14.04.20061 мин чтения
Guidance for Industry on Exocrine Pancreatic Insufficiency Drug Products-Submitting New Drug Applications; Availability
Локальный автоматический перевод · Язык оригинального источника
Краткое содержание
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.