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FDA Guidance for Industry: Considerations in Demonstrating Interchangeability With a Reference Product

Origin/Publisher:

FDA

Content:
This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)).

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