fda
fda. Means the United States Food and Drug Administration or its successor Entity.
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GT Biopharma, Inc. contract
fda. Means the United States Food and Drug Administration or successor agency thereto.
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ACHIEVE LIFE SCIENCES, INC. contract
fda. The United States Food and Drug Administration, or any successor agency having regulatory jurisdiction over the manufacture, distribution and sale of drugs in the United States, and its territories and possessions
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AmpliPhi Biosciences Corp contract
fda. The United States Food and Drug Administration or any successor thereto having the administrative authority to regulate the investigation, development, and marketing of human pharmaceutical products in the United States.
fda. The Food and Drug Administration of the United States, or any successor entity
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NOVELION THERAPEUTICS INC. contract
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