REGULATORY
PMDA Expresses Distrust of MSD for Deviations from GCP in Trials of Gardasil
The new drug application (NDA) review report issued on the cervical cancer vaccine Gardasil (human papillomavirus quadrivalent vaccine, recombinant), approved on July 1, has revealed that a number of problems were found in clinical trials conducted in Japan and abroad…
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REGULATORY
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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…





