clinical hold

(11)The term “financial hold”— (A)means an order issued by the Secretary to prohibit the sponsor of a clinical investigation from continuing the investigation if the Secretary determines that the investigation is intended to support a biosimilar biological product application and the sponsor has failed to pay any fee for the product required under subparagraph (A), (B), or (D) ofsection 379j–52(a)(1) of this title; and (B)does not mean that any of the bases for a “clinical hold” undersection 355(i)(3) of this titlehave been determined by the Secretary to exist concerning the investigation.


21 USC § 379j-51(11)

Scoping language

None: Default is title Scope
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