FDA Approval definition
FDA Approval means, with respect to a pharmaceutical product, any regulatory approval, licensure or authorization granted by the FDA, where such approval, licensure or authorization is required for the recipient to commence marketing or selling such pharmaceutical product in the United States.
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.
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
Following the First FDA Approval, the Non-publishing Party shall have no right to review or comment on any publications, abstracts, presentations or other publications of the Publishing Party, subject to the obligations of non-disclosure and restrictions on use set forth herein with respect to Confidential Information.
The JSC shall meet at least [*] per [*] (spaced at regular intervals) during the Technology Transfer Period and, after the end of the Technology Transfer Period, at least [*] per [*] (spaced at regular intervals) until the First FDA Approval, unless the Parties mutually agree in writing upon a different frequency.
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 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 receipt of all Regulatory Approvals from the FDA that would permit a Person to sell the Products in the United States.
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.