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# Exocrine Pancreatic Insufficiency NDA Guide Withdrawn
- URL: https://www.fdaweb.com/exocrine-pancreatic-insufficiency-nda-guide-withdrawn/
- Published: 2020-03-05T12:00:00.000Z
- Updated: 2026-09-14T16:05:59.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5146248

*Federal Register* notice: FDA is withdrawing its 2006 guidance entitled “Exocrine Pancreatic Insufficiency Drug Products — Submitting NDAs.” Under the Biologics Price Competition and Innovation Act of 2009, FDA no longer can accept NDAs for such products and instead sponsors must submit BLAs. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-03-05/pdf/2020-04531.pdf?ref=fdaweb.com).