# Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products: Draft Guidance for Industry - FDA Guidance Document

Source: https://www.keypedia.com/guidances/guidance-document/demonstrating-substantial-evidence-of-effectiveness-for-human-drug-and-biological-products-draft-guidance-for-industry/acd76b75-b054-4cf6-adbc-f122f9fb9c03

> FDA guidance document: Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products: Draft Guidance for Industry. Issue date: June 24, 2026. Get complete insights and analysis.

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## Details

- Title: Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products: Draft Guidance for Industry
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Office of the Commissioner
- Office URL: /offices/office-of-the-commissioner/79483979-9582-427f-ac3d-46c715811424
- Issue Date: 2026-06-24
- Comment Close Date: 2026-09-22
- Last Changed: 2026-06-22
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2019-D-4964">FDA-2019-D-4964</a>

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