fda
fda. The United States Food and Drug Administration or any successor agency having the administrative authority to regulate the approval for testing or marketing of human pharmaceutical or biological therapeutic products in the United States
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MELINTA THERAPEUTICS, INC. contract
fda. The United States Food and Drug Administration, or other similar foreign judicial, governmental or regulatory bodies having jurisdiction over the conduct of the clinical studies
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OSIRIS THERAPEUTICS, INC. contract
fda. The United States Food and Drug Administration (or its successor agency) and/or the corresponding governmental or other authority in another country, as applicable, such as the European Agency for the Evaluation of Medicinal Products (or "EMEA") in Europe
fda. United States Food and Drug Administration, any successor agency thereto, or any court, tribunal, arbitrator, agency, commission, official or other instrumentality of any federal, state, county, city or other political subdivision, domestic or foreign, that performs a function for such political subdivision similar to the function performed by the FDA for the United States with regard to the approval, licensing, registration or authorization to test, manufacture, promote, market, distribute,...
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LUNA INNOVATIONS INC contract
fda. The United States Food and Drug Administration or any successor entity thereto or any applicable Regulatory Authority as defined in the Product Master Plan
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HALOZYME THERAPEUTICS INC contract
fda. Means the United States Food and Drug Administration, any comparable agency in any Foreign Jurisdiction, and any successor agency or entity to any of the foregoing that may be established hereafter.
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HALOZYME THERAPEUTICS INC contract
fda. The United States of America Food and Drug Administration and any successor thereto
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BIOMARIN PHARMACEUTICAL INC contract
fda. The United States Food and Drug Administration (or its foreign equivalent in Japan or Europe).
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ARQULE INC contract
fda. The United States Food and Drug Administration, any successor agencies or departments, or any other federal agency serving in the same or similar function
fda. Defined in the License Agreement
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