Module 18 2021

08/02/2021

Drug/device evaluation

• In many instances, drug and device components will already be established:

• E.g. Progesterone in an IUD, NSAID in a patch

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Drug/device evaluation Some considerations ….

• Are the constituent parts already approved for an indication?

• Does the combination product expose the patient to a new route of administration or a new local or systemic exposure profile for an existing indication? • Is the drug formulation different to that used in the already approved drug? • Are the device and drug constituents chemically, physically, or otherwise combined into a single entity?

• Is the combination intended to treat a different patient population?

The Organisation for Professionals in Regulatory Affairs

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