FDA Filings definition

FDA Filings shall have the meaning given the term in Section 5.21.
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Examples of FDA Filings in a sentence

  • To Borrower’s knowledge, the FDA Filings contain all information required or necessary as a condition to approval by the United States Food and Drug Administration of products manufactured, marketed, sold or distributed by Borrower, and Borrower has no knowledge of any denial or reasonable basis for denial of approval of the FDA Filings and /or the medical device 510K filings with respect to products and devices manufactured, imported, marketed, sold or distributed by Borrower.

  • With respect to all notifications, applications, registrations, listings and other filings made with the United States Food and Drug Administration (collectively, the “FDA Filings”) by or on behalf of Borrower, none of the FDA Filings contains any untrue statement of material fact or omits to state a material fact necessary to make the statements contained in the applicable filing, in light of the circumstances under which they were made, misleading.

Related to FDA Filings

  • Company Filings means all documents publicly filed by or on behalf of the Company on SEDAR since January 1, 2020.

  • Regulatory Filings means all applications, approvals, licenses, notifications, registrations, submissions and authorizations made to or received from a Regulatory Authority in the Territory necessary for the development, manufacture or commercialization of a pharmaceutical product, including any INDs, NDAs and Regulatory Approvals.

  • Regulatory Authorizations means all approvals, clearances, authorizations, registrations, certifications, licenses and permits granted by any Regulatory Authority.

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • Filings shall have the meaning specified in Section 6 of this Agreement.