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ELEMENTS OF A REGULATORY INSPECTION

WHAT YOU NEED TO KNOW

While audits of studies with pending marketing applications are considered routine, FDA has recently shifted its focus toward an early intervention paradigm. Under this design, BIMO inspections occur prior to trial completion.

This approach allows FDA the opportunity to affect proactive change and continuously improve clinical investigator compliance. Early intervention inspections can be more difficult to predict as the audits are not necessarily triggered by a sponsor regulatory submission.

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Elements of a Regulatory Inspection

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