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 in section 262(k)(4) of title 42 .

Source

21 USC § 379j-51(14)


Scoping language

None identified. Default scope is assumed to be the entire title.
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