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Onsite inspections will remain the “irreplaceable standard” and are not going away anytime soon, despite the heavy reliance on remote tools to assess medicine manufacturing facilities during the ...

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The office tasked with overseeing pharmaceutical quality within the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) released its annual report for 2020 on ...

FDA’s Center for Drug Evaluation and Research implements its reorganization to bolster programs and policies to ensure drug with its “super” Office of Pharmaceutical Quality (OPQ). A greatly expanded ...

As of 9:07:05 AM GMT+2. Market Open. Loading chart for OPQ.F ...