FDA Approval definition

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.

FDA Approval means the final regulatory approval of the FDA required to commence commercial marketing of a health product.

FDA Approval means, in respect of the Products, all necessary Regulatory Approvals granted by the FDA for the manufacture, sale and distribution of the Products in the United States.

Examples of FDA Approval in a sentence

• As of the Effective Date, the Product has not received FDA Approval.

• Seller and its Affiliates have commenced, will commence, or Seller shall cause its Affiliates to commence, Marketing in the United States of the Rare Pediatric Disease product for which the Priority Review Voucher was awarded [***] period beginning on the date of the FDA Approval of such Rare Pediatric Disease product (such period, the “Marketing Period”).

• The Seller shall, directly or indirectly through its Affiliates or any Collaboration Partners, use Commercially Reasonable Efforts to conduct its Product Commercialization and Development Activities, to obtain SNDA FDA Approval and to Commercialize the Product within its approved indications for use.

• As of the Effective Date, the Company is planning to conduct all Clinical Trials, including Phase 3 Clinical Trials, necessary to (a) meet the Phase 3 Success Criteria and (b) receive FDA Approval, in each case of clauses (a) and (b), for the Product as the Product exists as of the Effective Date.

More Definitions of FDA Approval

FDA Approval means the approval of the United States Food and Drug Administration necessary for the marketing, distribution in interstate commerce and sale of the Initial Product (as defined in the Collaboration and License Agreement) in the United States.

FDA Approval means clearance for marketing by the FDA under Section 510(k) of the Act, 21 U.S.C. §360(k), and 21 C.F.R. Part 807, Subpart E, or FDA premarket approval granted in accordance with 21 U.S.C. § 360e and 21 C.F.R. Part 814.

FDA Approval means the approval of the new drug application (NDA) for the Finished Product by the Food and Drug Administration in the United States of America (FDA).

FDA Approval means the FDA approval under 42 U.S.C. § 262(k) of a biologics license application (BLA) authorizing the manufacture and introduction or delivery for introduction into interstate commerce of AVT02 in the United States by the Issuer (or as relevant, any member of the Group), granted to the Issuer (or as relevant, any member of the Group) by FDA of the United States; and for the avoidance of doubt, such an FDA Approval does not include an accelerated approval permitted under 21 U.S.C. 356(c) and 21 C.F.R. part 601, subpart E;

FDA Approval means written receipt from the FDA of approval for marketing a Product in the United States with an approved label including an indication for the Opioid Overdose Indication.

FDA Approval means an approval from the FDA or regulatory approval in a country in the TERRITORY after completion of appropriate trials to obtain marketing approval for a LICENSED PRODUCT.

FDA Approval means the receipt by Medtronic of all approvals by the FDA necessary or required for the commercialization in the United States of a Royalty Product.