# M9 Biopharmaceutics Classification System-Based Biowaivers - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/m9-biopharmaceutics-classification-system-based-biowaivers/bf9d33a6-a7bf-4b4e-bf7a-2a88d1e6d1cf

> FDA guidance document: M9 Biopharmaceutics Classification System-Based Biowaivers. Issue date: May 11, 2021. Get complete insights and analysis.

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## Details

- Title: M9 Biopharmaceutics Classification System-Based Biowaivers
- 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: 2021-05-11
- Last Changed: 2023-05-02
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2018-D-3614">FDA-2018-D-3614</a>

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