RAPS

FDA’s OPQ 2021 report focuses on pandemic responses

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 ...
RAPS

FDA’s OPQ reports on drug quality efforts in 2020

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 ...
PharmTech

OPQ Sets Stage for FDA’s Realigned Drug Oversight Structure

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 ...