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[0898] Therapeutic Agent: The term "therapeutic agent" refers to an agent that, when administered to a subject, has a therapeutic, diagnostic, and/or prophylactic effect and/or elicits a desired biological and/or pharmacological effect
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Rocket said it has met with leaders from the FDA’s Center for Biologics Evaluation and Research (CBER) to “align on the limited scope” of additional chemistry, manufacturing and controls (CMC) information and support Kresladi’s approval as soon as possible
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