# Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence - FDA Guidance Document

Source: https://www.keypedia.com/guidances/guidance-document/demonstrating-substantial-evidence-of-effectiveness-with-one-adequate-and-well-controlled-clinical-investigation-and-confirmatory-evidence/b9da6d6b-ce16-4b00-8230-317aa96fa4e7

> FDA guidance document: Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence. Issue date: September 19, 2023. Get complete insights and analysis.

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## Details

- Title: Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence
- 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: 2023-09-19
- Comment Close Date: 2023-12-18
- Last Changed: 2023-11-30
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2023-D-2318">FDA-2023-D-2318</a>

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