# Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/considerations-for-the-design-and-conduct-of-externally-controlled-trials-for-drug-and-biological-products/9dafe0c9-19d4-48c0-a1ca-6b2a04a813ed

> FDA guidance document: Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products. Issue date: February 01, 2023. Get complete insights and analysis.

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## Details

- Title: Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products
- 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: 2023-02-01
- Comment Close Date: 2023-05-02
- Last Changed: 2023-01-31
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2022-D-2983">FDA-2022-D-2983</a>

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