REGULATORY
PMDA’s Next 5-Year Plan to Embrace New Generic Unit, Benchmarks for Review Time
The Pharmaceuticals and Medical Devices Agency (PMDA) intends to stipulate the establishment of a generic review unit and targets for the overall review time for generics and new drugs in its next five-year plan starting in April. A draft for…
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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…





