Definitions

For purposes of this subpart: The term “affiliate” means a business entity that has a relationship with a second business entity if, directly or indirectly— Such term does not include— an application filed under section 262(k) of title 42 with respect to— The term “biosimilar biological product establishment” means a foreign or domestic place of business— The term “biosimilar initial advisory meeting”— means a meeting, if requested, that is limited to— The term “costs of resources allocated for the process for the review of biosimilar biological product applications” means the expenses in connection with the process for the review of biosimilar biological product applications for— The term “financial hold”— The term “process for the review of biosimilar biological product applications” means the following activities of the Secretary with respect to the review of submissions in connection with biosimilar biological product development, biosimilar biological product applications, and supplements: Postmarket safety activities with respect to biologics approved under biosimilar biological product applications or supplements, including the following activities: