# Considerations for Rescinding Breakthrough Therapy Designation - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/considerations-for-rescinding-breakthrough-therapy-designation/adc0ae37-722c-4b21-90ea-5a2087f771f0

> FDA guidance document: Considerations for Rescinding Breakthrough Therapy Designation. Issue date: June 24, 2022. Get complete insights and analysis.

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## Details

- Title: Considerations for Rescinding Breakthrough Therapy Designation
- 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: 2022-06-24
- Comment Close Date: 2022-08-23
- Last Changed: 2022-06-24
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2021-D-1152">FDA-2021-D-1152</a>

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