Biosimilar Advisory Committee Reviews: Necessity Or Nuisance?
FDA panelists' confusion over biosimilarity and overwhelming approval endorsements following glowing agency reviews suggest the meetings may not be having much impact on FDA deliberations; however, agency sees an opportunity to learn from what its external experts don't understand about biosimilars.
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Power To The (Adcomm) People: Members Believe Votes Should More Directly Affect US FDA Decisions
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There are strong reasons to justify an advisory committee meeting for the NASH application, but also an outlet for the US FDA to skip it.