REGULATORY
PMDA to Kick Off Pilot Program for Electronic Filings of NDA Data in October
The Pharmaceuticals and Medical Devices Agency (PMDA) will launch a pilot program this month for a proposed electronic data filing system, where drug makers submit clinical trial data for their new drug applications (NDAs) in electronic formats. The PMDA is…
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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…





