FDA Applications definition

FDA Applications means all investigational new drug applications, new drug applications, supplemental new drug applications, drug master files, abbreviated new drug applications, device premarketing applications, and all supplements or amendments thereto.
Sample 1Sample 2
FDA Applications means all investigational device applications, 510(k) premarket notifications, premarket approval applications, supplemental premarket approval applications, master files, as defined in 21 C.F.R. § 814.3, and all supplements or amendments thereto, whether pending or approved or cleared by the FDA. “EU Applications” means all XX Xxxxx, and any applications or assessments to obtain marketing authorizations in the EU, whether pending or approved or cleared by the
Sample 1
FDA Applications means all investigational new drug applications, new drug applications, supplemental new drug applications, abbreviated new drug applications, biologic license applications, drug master files, as defined in 21 C.F.R. § 314.420, establishment registrations, as defined in 21 C.F.R. § 207, product listings, as defined in 21 C.F.R. § 207, and cGMP submissions and all supplements or amendments thereto.
Sample 1

Examples of FDA Applications in a sentence

  • Except as set forth on Schedule 3.17(d) of the Company Disclosure Letter, no Marketing Approvals and Applications is held in the name of any Person other than the Company and no Person other than the Company has any right in or to any of such FDA Applications.

  • Requiring TPPI studies to compare new 71 FDA, Applications for Premarket Review of New Tobacco Products: Guidance for Industry, Draft Guidance (September 2011).

  • It would also reduce the significant compliance burden, and focus on the ultimate beneficial owner (“UBO”), which is the key concern in treaty shopping.Our recommendation would therefore be to look to the UBO.

  • It is important to understand causes of changes and how one change factor relates to anoth- er (Motawa et al., 2007).

  • Notwithstanding anything to the contrary contained in the Agreement, including, but not limited to, Section 12(c)(i), Hospira shall be solely responsible for preparing, filing and obtaining approval of all applications in countries of the Non-U.S./Canada Territory that are of the same nature as FDA Applications.

  • All FDA Applications that are owned by a Transferred Entity are in good standing, subsisting, not abandoned, and are, to the knowledge of Seller, valid and enforceable.


More Definitions of FDA Applications

FDA Applications means all investigational new drug applications, new drug applications, supplemental new drugapplications, drug master files, abbreviated new drug applications, device premarketing applications, and all supplements or amendments thereto.
Sample 1

Related to FDA Applications

  • SAP Application(s) means all Packages (i.e. all Software and Third Party Software) licensed under the Agreement and/or SAP cloud services for which Customer has a valid subscription, excluding User Interfaces for ERP, SAP Technology Solutions and all database Packages.

  • Patent Applications means all published and unpublished nonprovisional and provisional patent applications, reexamination proceedings, invention disclosures and records of invention, applications for certificates of invention and priority rights, in any country and regardless of formal name, including without limitation, substitutions, continuations, continuations-in-part, divisions, renewals, revivals, reissues, re-examinations and extensions thereof.

  • Third Party Applications means online, Web-based applications and offline software products that are provided by third parties and are identified as third-party applications, including but not limited to those listed on the AppExchange and the Reseller Application.

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

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Patent Application means an application for patent protection for a CRADA Subject Invention with the United States Patent and Trademark Office (“U.S.P.T.O.”) or the corresponding patent-issuing authority of another nation.

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

  • FCC Applications means those applications and requests for waivers required to be filed with the FCC to obtain the approvals and waivers of the FCC pursuant to the Communications Act and FCC Rules necessary to consummate the transactions contemplated by this Agreement.

  • 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 such 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.

  • FDA Approval means the approval by the FDA of a premarket approval application to market and sell a Product, as evidenced by the publication of such approval by the FDA.

  • Access Application means an application for Access Rights as described in section 3.7;

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • 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.

  • Renewal Application means a document used to collect pertinent data for renewal of permits

  • Software Application means a digital product or service as defined in Article 2, point 13, of Regulation (EU) …/… [on contestable and fair markets in the digital sector (Digital Markets Act)];

  • Project Application means the federal Section 5311 operating assistance project application submitted by the Municipal Corporation to, and as approved by the Commissioner for the Project described in Appendix C of this Agreement, including all project supporting information submitted therewith.

  • Athlete Application means the form set by the NZOC that must be completed by any Athlete applying to be nominated and selected to the Games Team.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • 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.

  • Initial application means the Application first provided to MFA on or before an Application Deadline to request an allocation of Tax Credits.

  • Application Process means the online application process under which the Applicant applies for Hospitality Packages on the Webshop.

  • Time of application means the date a participating lender receives an application from a participating community.

  • international application means an application filed under this Treaty;

  • Applications means all of the following: “New Drug Application” (“NDA”), “Abbreviated New Drug Application” (“ANDA”), “Supplemental New Drug Application” (“SNDA”), or “Marketing Authorization Application” (“MAA”), the applications for a Product filed or to be filed with the FDA pursuant to 21 C.F.R. Part 314 et seq., and all supplements, amendments, and revisions thereto, any preparatory work, registration dossier, drafts and data necessary for the preparation thereof, and all correspondence between the Respondent and the FDA related thereto. The term “Application” also includes an “Investigational New Drug Application” (“IND”) filed or to be filed with the FDA pursuant to 21 C.F.R. Part 312, and all supplements, amendments, and revisions thereto, any preparatory work, registration dossier, drafts and data necessary for the preparation thereof, and all correspondence between the Respondent and the FDA related thereto.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.