Module 18 - Drug Device Combinations and Other Technologies

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04/12/2023

Public

Common Issues

• Misinterpretation of the Rule 21 Devices that require a Medicines CA Consultation • GSPR 12.2 and its applicability to other devices • Interpretation of what is meant by locally dispersed • Data requirement expectations and need to conduct extensive ADME Studies • For topically applied products an unwillingness to accept that such products may be absorbed or locally dispersed

Public

Key Takeaways on Rule 21

• Understand the history and intent of this Rule • This is a new rule for all stakeholders and it shall evolve • Keep informed and up to date on guidance documents • Share experiences – the Good, Bad and Ugly

All of us might wish at times that we lived in a more tranquil world, but we don’t . And if our times are difficult and perplexing, so are they challenging and filled with opportunity”

Engage with all Stakeholders

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R. Kennedy

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