FDA Filings definition
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.