Pre-Approval Inspections and Alternative Approaches to Facility Assessment (4/15) Global Quality

Mahesh Ramanadham and Derek Smith, CDER Office of Pharmaceutical Quality, note that during the COVID-19 public health emergency, FDA is utilizing all available tools and sources of information to support regulatory decisions on applications that include sites impacted by FDA’s ability to inspect due to COVID-19. They discuss OPQ's approach to manufacturing facility assessment.

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