Module 18 - Drug Device Combinations and Other Technologies

13/12/2023

Common DDC file issues

Quality – Insufficient drug substance data – Control of elution of drug substance – Validation of analytical methods – Stability: accelerated testing; no degradation product testing Clinical – Data presented do not support the claims proposed – Benefit/risk not clearly defined – Poor/ lack of usefulness report from Notified Body

The Organisation for Professionals in Regulatory Affairs

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Common DDC file issues

 Lack of supportive data provided initially  CTD headings not addressed

Summarised data as evidence that finished product can be reproducibly manufactured and stored within specifications established from safety and clinical data

The Organisation for Professionals in Regulatory Affairs

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