NDA definition

NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.

NDA means a New Drug Application, or similar application for marketing approval of a Product for use in the Field submitted to the FDA, or its foreign equivalent.

NDA means a New Drug Application filed with the FDA.

Examples of NDA in a sentence

• The Receiver will notify the Discloser immediately of any breach of this NDA of which it becomes aware, and will assist and cooperate with the Discloser in minimizing the consequences of such breach.

• SHARING After the Effective Date, and at a time to be agreed upon by ONCOX and RGENE in the Definitive Agreement, RGENE would transfer to ONCOX in English that data related to any Licensed Products in RGENE’s possession and control that is required by regulatory authorities for opening an IND, NDA.

• A copy of each signed and witnessed NDA shall be submitted to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

• The obligations under this NDA will continue in effect for three (3) years from the date of last disclosure.

• SHARING After the Effective Date, and at a time to be agreed upon by XXXXX and ABVC in the Definitive Agreement, ABVC would transfer to ONCOX in English that data related to any Licensed Products in ABVC’s possession and control that is required by regulatory authorities for opening an IND, NDA.

More Definitions of NDA

NDA means a New Drug Application (as more fully defined in 21 C.F.R. 314.5 et seq. or its successor regulation) and all amendments and supplements thereto filed with the FDA.

NDA means a New Drug Application, Biologics License Application, Marketing Authorization Application, filing pursuant to Section 510(k) of the United States Federal Food, Drug and Cosmetic Act, or similar application or submission for a marketing authorization of a product filed with a Regulatory Authority to obtain marketing approval for a biological, pharmaceutical or diagnostic product in that country or in that group of countries.

NDA means a New Drug Application submitted and filed with the FDA or the equivalent application or filing filed with any equivalent agency or government authority outside of the United States (including any supra-national agency such as in the European Union) necessary for approval of a drug in such jurisdiction.

NDA means a New Drug Application filed with the FDA as described in 21 C.F.R. § 314, a Biological License Application (BLA) pursuant to 21 C.F.R. § 601.2, or any equivalent or any corresponding application for regulatory approval in any country or regulatory jurisdiction other than the United States.

NDA means a new drug application (as defined in Title 21 of the United States Code of Federal Regulations, as amended from time to time) filed with the FDA seeking Regulatory Approval to market and sell any Licensed Product in the United States for a particular indication within the Field.

NDA means the new drug application for a product, including the Product, requesting permission to place a drug on the market in accordance with 21 C.F.R. Part 314, and all supplements filed pursuant to the requirements of the FDA, including all documents, data, and other information filed concerning such product that are necessary for FDA approval to market such product in the Territory.

NDA means a new drug application, biological license application or establishment license application, as applicable, and all amendments and supplements thereto, filed or to be filed, with the FDA seeking authorization and approval to Manufacture, package, ship and sell the Product as more fully described in the Regulations.