Regulatory Approval Application

Example Definitions of "Regulatory Approval Application"
Regulatory Approval Application. Means, with respect to a particular indication for a Product, the submission to the relevant Governmental Authority of an application seeking any Regulatory Approval, and shall include a marketing authorization application, supplementary application or variation thereof, NDA or any equivalent application in Japan.
Found in Durata Therapeutics, Inc. contract
Regulatory Approval Application. An application submitted to the appropriate Regulatory Authority seeking Regulatory Approval of a Marketed Product for use in one or more therapeutic indications in a regulatory jurisdiction
Found in Aravive, Inc. contract
Regulatory Approval Application. Shall mean an application submitted to a Regulatory Authority seeking Regulatory Approval for a Licensed Product.
Found in Centessa Pharmaceuticals Ltd contract
All Definitions