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 filed with the FDA.

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.

Examples of NDA in a sentence

• The terms and conditions of the NDA are hereby incorporated by reference herein, and Tenant acknowledges that any breach thereof on the part of Tenant or any “Prospect Representative” (as such term is defined in the NDA) shall constitute a material default hereunder entitling Landlord to terminate the Option and retain the Option Payment as consideration for the Option and the other rights granted to Tenant hereunder.

• This Consortium Agreement consists of this core text and: − Attachment 1 (Background included) − Attachment 2 (Accession document) − Attachment 3 (List of third parties for simplified transfer according to Section 8.3.2) − Attachment 4 (Identified entities under the same control ) − Attachment 5 (NDA for External Expert Advisory Board agreed under Section 6) In case the terms of this Consortium Agreement are in conflict with the terms of the Grant Agreement, the terms of the latter shall prevail.

• At Customer’s written request, and provided that the parties have an applicable NDA in place, AWS will provide Customer with a copy of the Report so that Customer can reasonably verify AWS’s compliance with its obligations under this DPA.

• The Non-Disclosure Agreement entered into by the Parties as of (add a corresponding date) (the “NDA”) is applicable to the Joint Venture and shall apply in full force and effect to any and all Confidential Information (as defined in the NDA) exchanged or otherwise accessed by a Party under this Agreement.

• The parties will treat all confidential information exchanged between the parties under this Agreement in accordance with the separate nondisclosure agreement ("NDA") executed by the parties.

More Definitions of NDA

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 that is required for approval for the Product in the United States, or its foreign equivalent 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.

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 or product license application or its equivalent filed with and accepted by the FDA after completion of human clinical trials to obtain marketing approval for a Product, or any comparable application filed with and accepted by the regulatory authorities of a country other than the United States, including, where applicable, any applications for governmental pricing and marketing approval.

NDA means a new drug application for a drug filed 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 concerning the applicable drug which are necessary for FDA approval to market such drug in the United States, and any equivalent application submitted to any other health authority.

NDA means: (a) in the United States, a New Drug Application (as more fully defined in 21 CFR 314.5, et seq.) filed with the FDA, or any successor application thereto; or (b) in any other country or group of countries, the equivalent application or submission for approval to market a pharmaceutical product filed with the governing Regulatory Authority in such country or group of countries.