Regulatory Filing & Pre- License/Pre-Approval Inspections of ...
Regulatory Filing & Pre- License/Pre-Approval Inspections of ...
Regulatory Filing & Pre- License/Pre-Approval Inspections of ...
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<strong>Pre</strong>-<strong>License</strong> & <strong>Pre</strong>-<strong>Approval</strong><strong>Inspections</strong>‣Conducted by CDER reviewers in DMPQ/BMTand OBP/DMA or OBP/DTP with BMT as thelead‣District invited to participate (domesticinspections)‣PLIs and PAIs are announced‣Biennial (or surveillance) inspections areconducted after approval typically by ORA26