US FDA definition

US FDA means the United States Food and Drug Administration and any successor regulatory agency.

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US FDA has the meaning set forth in Section 3.16(a).

US FDA means the US Food and Drug Administration as defined above, or any successor agency.

Examples of US FDA in a sentence

The Institution and the Investigator shall promptly notify PSI of any inspection or investigation relating to the Study by any regulatory, governmental or law agency (including without limitation the EMA and the US FDA) of which they become aware.
This approval may be sought by either the manufacturer or the local drug authority and takes approximately 8-12 weeks after receipt of the request by the US FDA.
AACR warrants that it is not debarred by a competent health authority (including, if applicable, the US FDA); AACR shall not employ, contract with or retain any person directly or indirectly to perform work under the Agreement if such a person is or becomes debarred by a competent health authority (including, if DocuSign Envelope ID: 2EF2A8A2-913E-4504-BFB8-7986B45EE82118 applicable, the US FDA).
Successful completion of the prototype project will demonstrate Regeneron’s capability to (i) rapidly manufacture product, which can be further scaled-up to meet mutually agreed to surge requirements with little advance notification and (ii) facilitate the Government’s ability to stockpile and distribute large quantities of the drug product to respond when needed, including for use in clinical studies, under an Emergency Use Authorization (EUA), or pursuant to other approval from the U.S. FDA.
This may be an NDA, INDA, IDE, PMA, ANDA, NADA, 510K or other appropriate reference to a filing with the US FDA.

More Definitions of US FDA

US FDA means the Food and Drug Administration of the United States of America.

US FDA means the United States Food and Drug Administration.

US FDA means the United Sates Food and Drug Administration or any successor governmental agency thereof.

US FDA has the meaning set forth in Section 3.16(a). FORM OF DEED1 After recording, return to:

US FDA means the United States Food and Drug Administration or any other successor agency whose approval is necessary to market the Product in the USA.

US FDA has the meaning set forth in Section 3.16(a). This ASSIGNMENT AND ASSUMPTION AGREEMENT (this “Assignment and Assumption”) is made and entered into as of October 2, 2017, by and among COCA-COLA REFRESHMENTS USA, INC., a Delaware corporation (“CCR”), COCA-COLA BOTTLING CO. CONSOLIDATED, a Delaware corporation (“CCBCC”), CCBCC OPERATIONS, LLC, a Delaware limited liability company (“CCBCC Operations”), RED CLASSIC EQUIPMENT, LLC, a North Carolina limited liability company (“Red Classic Equipment”), and RED CLASSIC TRANSIT, LLC, a North Carolina limited liability company (“Red Classic Transit” and together with CCBCC, CCBCC Operations, and Red Classic Equipment, the “CCBCC Parties” and each, a “CCBCC Party”).

US FDA means the U.S. Food and Drug Administration.