Module 15 2022

19/05/2022

Acceptability differs from applicability/suitability

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Use of Foreign Data

• For US market plans, it is important to understand FDA’s position on clinical data generated OUS to maximize the opportunity to leverage OUS data. • Review US Early Feasibility IDE route and compare to other options, to ensure there is no missed opportunity to a US-first approach • In OUS feasibility/pilot study try to assure that you are getting appropriate information in order to be able to design a meaningful pivotal study. • Apply appropriate GCP compliant procedures to early phase studies when they have potential to support submissions to FDA • Be aware that quality of data is important, but overall clinical applicability and suitability of the data to answer FDA questions are equally important

• Discuss and try to get agreement with FDA on use of OUS data before beginning study

• FDA is usually amenable to joint US/OUS studies if not full OUS studies.

• Mitigate your risks of acceptance by performing a full GCP/local regulations audit

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