# Investigational Enzyme Replacement Therapy Products:  Nonclinical Assessment:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/investigational-enzyme-replacement-therapy-products-nonclinical-assessment-guidance-for-industry/a3c5d661-a82f-441e-9036-1639578d4fc9

> FDA guidance document: Investigational Enzyme Replacement Therapy Products:  Nonclinical Assessment:  Guidance for Industry. Issue date: October 03, 2019. Get complete insights and analysis.

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## Details

- Title: Investigational Enzyme Replacement Therapy Products:  Nonclinical Assessment:  Guidance for Industry
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2019-10-03
- Comment Close Date: 2020-01-02
- Last Changed: 2020-04-24
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2015-D-1246">FDA-2015-D-1246</a>

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