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

FDA Approval Summary: Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Disease Progression on or After Platinum-Containing Chemotherapy.

Applications for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed, 68 Fed.

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 receipt by Parent, any of its controlled Affiliates or any Assignee, on or before the Regulatory Approval Payment Target Date, of a final approval letter from the FDA with respect to a new drug application for the Product, which approval letter grants Parent, any of its controlled Affiliates or any Assignee the right to market and sell the Product for use in the United States for the treatment of opioid induced constipation.
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 sale and marketing of Heplisav-B has been approved by the FDA for labeled indication that includes immunization against infection caused by all known subtypes of hepatitis B virus in adults 18-70 years of age with no BLACK BOX warning, a 2 dose regimen, and clinical data demonstrating Heplisav-B provided a statistically significantly higher rate of seroprotection than Engerix-B.
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.