Association for Accessible Medicines
FDANonrulemakingFDA-2019-D-2102

Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations; Draft Guidance for Industry; Availability

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Association for Accessible Medicines filings
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Association for Accessible Medicines filed 1 comment on this docket between Jul 23, 2019 and Jul 23, 2019. 0 other organizations filed here. The comment window closed 2563d ago.

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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of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations; Draft Guidance for Industry.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.

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Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations; Draft Guidance for Industry; Availability (FDA) — Association for Accessible Medicines | OpenPolis