At this week's FDA meeting on PAT and QbD, someone in the audience asked CDER Deputy Director Keith Webber, who had spoken about PAT, QbD, process validation (old vs. new) and real time release vs. end of line testing, whether FDA would ever require PAT.
PAT Won't Be Mandated (But Don't Look for Any New Incentives Either): CDER Deputy Director Webber
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