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FDA issues Final Guidance on Considerations in Demonstrating Interchangeability with a Reference Pro

Increase font size  Decrease font size Date:2019-05-16   Views:18

The U.S. Food and Drug Administration (FDA) issued final guidance for industry "Considerations in Demonstrating Interchangeability With a Reference Product” and announced the release in an FDA statement. 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 the Public Health Service Act (PHS Act).

 
 
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