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  • su65 replied to the topic Combination Product in the forum Regulatory Basics for Medical Devices 8 years, 3 months ago

    Transdermal patch is a combination product which is used to deliver drugs through skin. Currently around 17 drug molecules are approved by FDA for transdermal delivery. The patch has micro needles which will deliver the drug through the skin. The application pathway for this would be submitting application at CDER under NDA/ANDA because the the drug constitues the PMOA. It should undergo invitro testing to determine the safety and action of the drug.