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 after completion of Clinical Studies to obtain Approval for a Product in the United States.
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 Bonus Shares shall be issued at a price per share equal to the fair market value per share of Common Stock as of the time of the relevant NDA Approval.
For the avoidance of doubt, all Participants must execute a Lender NDA, with such changes as requested by such Participant as may be approved by the Borrower, prior to such Participant’s receipt of any confidential information of the Borrower.
More Definitions of NDA
NDA means a new drug application.
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, 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 covering a Product filed with the FDA pursuant to Section 505(b)(1) of the Act, or any similar application or submission seeking Regulatory Approval of a Product filed with the applicable Regulatory Authority in another country or region, to obtain Regulatory Approval for the Product, together with any amendments thereto.
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, Biologics License Application or similar application for Marketing Approval of a Licensed Product submitted to the FDA, or other Regulatory Authority.