audit ready

When Does the FDA Perform PAIs?

12/05/2022

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Preapproval facility evaluations are conducted by a CDER integrated quality assessment (IQA) team to evaluate if a PAI is needed from a quality perspective before a NDA can be approved. A risk based approach is used with a focus on facility, product, and process.

Updated Sponsor CPGM: Focus on Remote Monitoring, CRO Oversight, Electronic Systems

9/28/2021

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The US Food and Drug Administration (FDA) released an updated Compliance Program Guidance Manual (CPGM) for sponsors in September 2021. CPGMs are used to guide FDA inspectors when conducting an inspection for subject protection and data quality and integrity as part of FDA's Bioresearch Monitoring Program (BIMO). Part III, Inspectional, is vastly expanded in line with the current way clinical trials are conducted, including remote monitoring, sponsor’s outsourcing of clinical trial activities, and clinical trials conducted outside the United States. The CPGM increases scrutiny of sponsor processes and procedures related to selection of investigators, electronic systems, and CRO oversight. The following are selected highlights of the changes.