The Pharmaceutical Evaluation Division of the Ministry of Health, Labor and Welfare’s (MHLW) Pharmaceutical Safety and Environmental Health Bureau has reported its revisions of its safety guidance to ensure the safety of first-in-human (FIH) studies in drug development, by adding…
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We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…





