# Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/interpreting-sameness-of-monoclonal-antibody-products-under-the-orphan-drug-regulations/31a4f2ab-649f-4be4-af24-4229e9d753c7

> FDA guidance document: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations. Issue date: April 01, 2014. Get complete insights and analysis.

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## Details

- Title: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Biologics Evaluation and Research
- Office URL: /offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d
- Issue Date: 2014-04-01
- Last Changed: 2018-12-01
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-1999-D-0178">FDA-1999-D-0178</a>

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