What is it about?
Analytical basis for establishing equivalence of hyaluronan products.
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Why is it important?
First documentation of some analytical methodology for establishing equivalence of hyaluronan products.
Perspectives
A portion of this data was used in obtaining the first Class III medical device approval under section 216 of the FDAMA of 1997.
Dr. Michael J Daley
OrthogenRx, Inc.
Read the Original
This page is a summary of: Rheological and molecular weight comparisons of approved hyaluronic acid products – preliminary standards for establishing class III medical device equivalence, Journal of Biomaterials Science Polymer Edition, December 2015, Taylor & Francis,
DOI: 10.1080/09205063.2015.1119035.
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