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.