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, biologic license applications, establishment registrations, as defined in 21 C.F.R. §207, and product listings, as defined in 21 C.F.R. §207, and all supplements or amendments thereto.
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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 ▇▇ ▇▇▇▇▇, and any applications or assessments to obtain marketing authorizations in the EU, whether pending or approved or cleared by the
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FDA Applications means all investigational new drug applications, new drug applications, supplemental new drug
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Examples of FDA Applications in a sentence

  • The Banner Companies are the sole legal owners of the regulatory approvals and related registration files for all products covered by the FDA Applications and other similar applications listed in Section 4.14(c) of the Disclosure Letter.

  • 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.

  • 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.

  • Except as set forth in Section 3.18 of the Seller Disclosure Schedule, no actions are due within ninety (90) days after Closing to maintain any such FDA Applications.

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  • Patent Applications means all published and unpublished nonprovisional and provisional patent applications, reexamination proceedings, invention disclosures and records of invention, applications for certificates of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 an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).