FDA Approval definition

FDA Approval means the approval, license, clearance or authorization of the FDA necessary for the marketing and sale of a product for human use in the United States.

Split View

AI-Powered Contracts

Draft, Review & Redline at the Speed of AI

Get StartedSchedule a Demo

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

Examples of FDA Approval in a sentence

• Patheon shall assist the Client, to the extent consistent with Patheon’s obligations under this Agreement, to obtain FDA Approval for the commercial manufacture of the Drug Product as quickly as reasonably possible.

• A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of BA058 in Healthy Postmenopausal Women ( Pending FDA Approval) Protocol Number: BA058-05-001 The study will be designed to: · Determine the safety and tolerability of multiple subcutaneous doses of BA058 in healthy postmenopausal women.

• The Client shall have the sole responsibility for filing all documents with the FDA and taking any other actions that may be required for the receipt of FDA Approval for the commercial manufacture of the Drug Product.

• Prior to the occurrence of the U.S. Commercial Launch, within thirty (30) days after each of June 30 and December 31 in each calendar year, Parent shall provide the Rights Agent with a written report describing in reasonable detail the activities Parent and its Affiliates have undertaken in the preceding 6-month period to develop, achieve U.S. Commercial Launch of and seek FDA Approval for the Product (each, a “Status Report”).

• II for all the costs (determined in accordance with Section 6.5 hereof) relating to the Manufacture and Sale of such ▇▇▇▇▇▇ Products prior to FDA Approval of such ▇▇▇▇▇▇ Products as Development Costs, and shall remit to ▇▇▇▇▇▇ Corp.

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

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, with respect to any Product, clearance by the FDA of a 510(k) application for such Product.