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antihama

05/11/24 6:20 AM

#690585 RE: Dan88 #690546

The first thing that came to mind when they discussed inspections not done is the FDA pre-approval inspection (PAI). That is one of the last things checked off (a couple of weeks of a month or 2 before), when approval is around the corner. Yes, this is the MHRA but I'm sure they go about their business in similar fashion. I'm not sure about clinical sites. I'm guessing they'll pick a couple of sites to visit corresponding to the clinical data they reviewed from the application package. That would be less complicated than a PAI inspection. Also, a PAI type inspection and a clinical site inspection could be done concurrently since different departments and inspectors are doing each type of inspection.