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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Outline‣ <strong>Regulatory</strong> authority‣ Organization‣ Application review‣ Review issues‣ <strong>Pre</strong>-license & <strong>Pre</strong>-approval inspections‣ FDA Form 483 Observations from BMTledinspections2