FDA Approval means the final regulatory approval of the FDA required to commence commercial marketing of a health product.
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 the receipt by Medtronic of all approvals by the FDA necessary or required for the commercialization in the United States of a Royalty Product.
Examples of FDA Approval in a sentence
On September 22, 2022, the Company's Compensation Committee certified 100% of the PSUs eligible to vest based on i) the achievement of the U.S. Food and Drug Administration's ("FDA") approval of the Issuer's biologics license application (BLA) for DAXXIFY(R) for the improvement of glabellar lines ("FDA Approval") and ii) subject to the Reporting Person remaining in continuous service through the six-month anniversary following the date of the FDA Approval which six-month anniversary was March 7, 2023.
More Definitions of FDA Approval
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 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 with respect to the Product, a Regulatory Approval by the FDA for the commercial use of the Product in the United States.
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 as used herein, shall mean a marketing approval for commercial distribution in the United States pursuant to Section 505 of the Food, Drug and Cosmetic Act, as amended. For clarity, an "FDA Approval" as used herein shall not include any "approvable" determinations by the U.S. Food & Drug Administration ("FDA"), including as set forth in any approvable letter under 21 CFR § 314.110.
FDA Approval means the issuances of the FDA’s approval letter enabling the Borrower to commercially promote, market, distribute and use KP201 in the United States for the treatment of acute pain in humans.
FDA Approval means all approvals from the United States Food and Drug Administration necessary for the commercial marketing and sale of a PyL Product in the United States.