Jul 23, 2019· Comment from Association for Accessible Medicines (AAM)· FDA-2019-D-2102-0014
Comments from the Association for Accessible Medicines (AAM) and its Biosimilars Council on behalf of our member companies, regarding FDA-2019-D-2102: Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations; Draft Guidance for Industry. Please find full comments enclosed.