FDA Approval definition

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 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.

Examples of FDA Approval in a sentence

• 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.

• 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”).

• In the case of each such product which has FDA Approval, said FDA Approval is currently in full force and effect, and there is no basis for any adverse change in or withdrawal of such FDA Approval.

• For the avoidance of doubt, no publication of a Class I recommendation contemplated by the Clinical Recommendation Milestone or approval of a premarket approval application contemplated by the FDA Approval Milestone occurring after the end of the applicable Clinical Recommendation Milestone Period or the FDA Approval Milestone Period, as applicable, shall result in any Milestone Payment becoming due and payable.

• In the case of those products which require or might require FDA Approval, where such Approval has not yet been obtained, said Exhibit Q specifies the expected schedule for obtaining said Approval.

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 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 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 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 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.