FDA Application definition

FDA Application means any investigational new drug application, new drug application, supplemental new drug application, abbreviated new drug application, investigational device exemption, premarket approval application, 510-K application, any other application required by the FDA to test, use, market, or distribute a pharmaceutical or biological product for human use, and any amendment to any of the foregoing.
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FDA Application means a new drug application as described in Code of Federal Regulations Title 21 (21 C.F.R.) § 314.50, submitted to the FDA under Section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355(b)) for approval to commercialize a drug product in the United States.
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Examples of FDA Application in a sentence

  • Neither the Company nor any of its officers, employees, contractors, and agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity to invoke a similar policy.

  • Neither the Company nor any of its officers, employees, or, to the Company’s knowledge, any of its contractors or agents is the subject of any pending or threatened investigation by FDA pursuant to the FDA Application Integrity Policy and any amendments thereto, or by any other similar governmental entity pursuant to any similar policy.

  • The Group agrees to retain all records resulting from the Study for the time required by applicable federal regulations (for the Study, the Company will notify the Group of the FDA Application filing and approval status).

  • Neither the Corporation nor any of its officers, employees, contractors, and agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity to invoke a similar policy.

  • The Research Organization shall retain all records resulting from the Research for the time required by applicable federal regulations (the Sponsor will notify the Research Organization of the FDA Application filing and approval status), and to allow for sponsor (or sponsor’s representative) and FDA inspection of all such records.

  • Neither the Company nor its Subsidiaries, nor to the Knowledge of the Company, any of their respective officers, employees, contractors or agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke the FDA Application Integrity Policy or for any similar Governmental Authority to invoke a similar policy with respect to the Company or any Company Product.

  • Neither the Company nor any of its officers or employees, or, to the Company’s knowledge, any of the Company’s independent contractors or Agents or any its manufacturing or clinical service providers, has committed any act, made any statement, or failed to make any statement, in each case with respect to the Company, that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity to invoke a similar policy.

  • For adjudication purposes, a drug that is approved by the U.S. Food and Drug Administration (FDA) and is distributed under an FDA Application Type of new drug application (NDA) or biologic license application (BLA), and which is not an Authorized Generic and which is not a House Generic.

  • Neither Athenen nor any of its officers, employees, contractors, and agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity to invoke a similar policy.

  • Neither Ultimate Parent nor any of its officers or employees, or to the Knowledge of Ultimate Parent, any of its contractors and agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity to invoke a similar policy.

Related to FDA Application

  • Planning Application means the application for [outline/full] planning permission dated [ ] bearing the Council’s reference number [ ];

  • Mobile Application means a specialized software program downloaded onto a wireless communication device.

  • Licensed Application means an Application that (a) meets and complies with all of the Documentation and Program Requirements, and (b) has been selected and digitally signed by Apple for distribution, and includes any additional permitted functionality, content or services provided by You from within an Application using the In-App Purchase API.

  • Biosimilar Application has the meaning set forth in Section 7.3.3.

  • Practical application means to manufacture in the case of a composition or product, to practice in the case of a process or method, or to operate in the case of a machine or system; and in each case, under these conditions as to establish that the invention is being utilized and that its benefits are to the extent permitted by law or Government regulations available to the public on reasonable terms.