> ## Content Index
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# Guide on Enzyme Replacement Therapy Products
- URL: https://www.fdaweb.com/guide-on-enzyme-replacement-therapy-products/
- Published: 2019-10-03T12:00:00.000Z
- Updated: 2026-09-15T01:54:12.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145157

*Federal Register* notice: FDA has made available a final guidance entitled “Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment.” The document is intended to help sponsors design and conduct nonclinical studies needed in (XXX SUBSTITUTE XXX) human clinical trials, ongoing clinical development, and marketing approval for such products. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-10-03/pdf/2019-21507.pdf?ref=fdaweb.com).