supplement

(14)The term “supplement” means a request to the Secretary to approve a change in a biosimilar biological product application which has been approved, including a supplement requesting that the Secretary determine that the biosimilar biological product meets the standards for interchangeability described insection 262(k)(4) of title 42.

Source

21 USC § 379j-51(14)


Scoping language

None: Default is title Scope
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