USA – FDA drafts guidance on classification category for biosimilar supplements

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12 mars 2024

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ELSIBI

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Hypothèses : carnets de recherches en Sciences humaines et sociales

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info:eu-repo/semantics/openAccess

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vroby, « USA – FDA drafts guidance on classification category for biosimilar supplements », ELSIBI, ID : 10.58079/w08c

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The US Food and Drug Administration (FDA) just published draft guidance to assist sponsors determine the appropriate supplement category for biosimilar applications and its goals for reviewing them. The guidance also describes the process for submitting supplements. The FDA Draft guidance can be found on its website. More information on RIS.World.

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