Examples of New Drug Application in a sentence

To the extent required by applicable laws and regulations of the FDA, the Company or the applicable Subsidiary has submitted to the FDA an Investigational New Drug Application or amendment or supplement thereto for each clinical trial it has conducted or sponsored or is conducting or sponsoring; all such submissions were in material compliance with applicable laws and rules and regulations when submitted and no material deficiencies have been asserted by the FDA with respect to any such submissions.
The records for all studies performed under an IND will be maintained, at a minimum, for two years after the approval of a New Drug Application (NDA).
The mixing together of two or more products does not constitute a "new" drug as regulated by the Food and Drug Administration (FDA) under the New Drug Application (NDA) process.
In such a case, the appropriate submission would be an Abbreviated New Drug Application (ANDA) that cites the duplicate product as the reference listed drug.
Note that records of IND studies must be kept until 2 years after a New Drug Application is approved/issued or for 2 years after the IND is withdrawn.

More Definitions of New Drug Application

New Drug Application or "NDA" means (a) the single application or set of applications for Products and/or pre-market approval to make and sell commercially both a formulation of Compound and a compatible commercial Device to be marketed as Product, filed by Lilly with the appropriate regulatory authority within the Territory, and (b) any related registrations with or notifications to the appropriate regulatory authority within the Territory. This term does not include any of Lilly's Regulatory Approvals in the Territory for any insulin products other than the Products contemplated in this Agreement.

New Drug Application or “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 (not including pricing and reimbursement approval) in any country or regulatory jurisdiction other than the United States.

New Drug Application or “NDA” means a new drug application filed with a Regulatory Authority (not including pricing and reimbursement approval), that is analogous to the new drug application with the United States Food and Drug Administration described in 21 C.F.R. § 314.

New Drug Application means a new drug application filed with the FDA under 21 U.S.C. § 355(b).

New Drug Application or “NDA” means an application submitted to the FDA pursuant to 21 USC Section 505(b), which contains complete details of the manufacture and testing of a new drug, for purposes of obtaining regulatory approval to market such new drug in the United States, for a particular indication, and also includes any Biologics License Application.

New Drug Application or "NDA" means a New Drug Application as defined in the United States Federal Food, Drug and Cosmetic Act and applicable regulations promulgated thereunder as amended from time to time.