Common use of NDA Clause in Contracts

NDA. The term “NDA” shall mean a new drug application, including all necessary documents, data, and other information concerning a Product, required for Regulatory Approval of the Product as a pharmaceutical product by the FDA or an equivalent application to the equivalent agency in any other country or group of countries (e.g. the marketing authorization application (MAA) in the EU).

NDA. The term “NDA” shall mean a new drug application, including all necessary documents, data, and other information concerning a Product, required for Regulatory Approval of the Product as a pharmaceutical product by the FDA FDA, or an equivalent application to the equivalent agency Regulatory Authority in any other country or group of countries (e.g. e.g., the marketing authorization application (MAA) in filed with the EUEMA).