351(k) Application definition

351(k) Application means a "biologics license application" (as such term is used under the PHSA) submitted under section 351(k) of the PHSA, including all subsequent submissions, supplements and amendments thereto, and any international equivalents.
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Related to 351(k) Application

  • Mobile Application means a specialized software program downloaded onto a wireless communication device.

  • L/C Application means an application and agreement for the issuance or amendment of a Letter of Credit in the form from time to time in use by the L/C Issuer.

  • SAP Application(s) means all Packages (i.e. all Software and Third Party Software) licensed under the Agreement and/or SAP cloud services for which Customer has a valid subscription, excluding User Interfaces for ERP, SAP Technology Solutions and all database Packages.

  • Biologics License Application or “BLA” means, with respect to a country or extra-national territory, a request for permission to introduce, distribute, sell or market a biologic product in such country or some or all of such extra-national territory, including pursuant to 21 CFR 601.2 in the U.S.

  • Access Application means an application for Access Rights as described in section 3.7;