Considerations in Demonstrating Interchangeability With a Reference Product: Update; Draft Guidance for Industry; Availability
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The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Considerations in Demonstrating Interchangeability With a Reference Product: Update." This draft guidance describes considerations regarding a switching study or studies intended to support a demonstration that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under the Public Health Service Act (PHS Act). After considering any comments received in the docket for this draft guidance, we intend to revise the final guidance for industry entitled "Considerations in Demonstrating Interchangeability With a Reference Product" issued on May 14, 2019, to amend sections in that document regarding the subject addressed in this draft guidance.
Abstract as published in the Federal Register.
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