# Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/accelerated-approval-and-considerations-for-determining-whether-a-confirmatory-trial-is-underway/ae83d008-58ac-4e99-bb05-ca1492236392

> FDA guidance document: Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway. Issue date: January 07, 2025. Get complete insights and analysis.

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## Details

- Title: Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway
- 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: 2025-01-07
- Last Changed: 2025-01-06
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2024-D-3334">FDA-2024-D-3334</a>

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