Business · 05/03/2020Updated: 10/17/2026 · 1 min read
FDA Withdraws Guidance for Exocrine Pancreatic Insufficiency Drug Products
Summary
The Food and Drug Administration (FDA) is withdrawing a 2006 guidance for industry related to submitting new drug applications for pancreatic enzyme products intended to treat exocrine pancreatic insufficiency (EPI), as the submission deadline for such applications has passed.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →