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FDA Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products under the Orphan Drug Regulations (Issued 1/2004, Posted 1/6/2004)


Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, ,

The purpose of this guidance is to describe the Agency’s current thinking on the criteria by which two monoclonal antibody products would be considered the same under the Orphan Drug Act and its implementing regulations

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