Module 18 - Drug Device Combinations and Other Technologies

05/12/2023

Guidelines – Drug Formulation

FDA Guidance - Early Development Considerations for Innovative Combination Products

In effect since 2006

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• Provides supplementary guidance to industry and FDA staff on developmental considerations for innovative products that combine devices, drugs and/or biological products

The Organisation for Professionals in Regulatory Affairs

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Drug/device evaluation

• In many instances, drug and device components will already be established: • E.g. Progesterone in an IUD, NSAID or opioid in a patch

The Organisation for Professionals in Regulatory Affairs

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