The
U.S. FDA has issued a new guidance document “Considerations in Demonstrating
Interchangeability With a Reference Product”.
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)).
This
guidance provides an overview of important scientific considerations in
demonstrating interchangeability with a reference product, including the
following: data and information needed to support a demonstration of
interchangeability; considerations for the design and analysis of a switching
study or studies to support a demonstration of interchangeability; considerations
regarding the comparator product in a switching study or studies; abbreviated
considerations for developing presentations, container closure systems, and
delivery device constituent parts for proposed interchangeable products.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
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