FDA Approval definition

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