# M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver: Draft Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/m13b-bioequivalence-for-immediate-release-solid-oral-dosage-forms-additional-strengths-biowaiver-draft-guidance-for-industry/ac185a33-db56-4b82-aaa5-ce74c415127c

> FDA guidance document: M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver: Draft Guidance for Industry. Issue date: May 30, 2025. Get complete insights and analysis.

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## Details

- Title: M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver: Draft Guidance for Industry
- 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: 2025-05-30
- Comment Close Date: 2025-08-01
- Last Changed: 2025-06-02
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2023-D-0093">FDA-2023-D-0093</a>

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