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GUIDANCE DOCUMENT

Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations April 2014

Final
Docket Number:
FDA-1999-D-0178
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

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Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-1999-D-0178.