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puneet replied to the topic FDA Approves First Digital Pill in USA in the forum Introduction to Project Management 7 years, 2 months ago
I think that the primary mode of action of the digital Abilify pill makes it a drug, rather than a device. This digital pill is more of a pill that comes with a sensor than it is a sensor that comes with a pill because the pill most important therapeutic action is the biological action by the drug portion of the combination product. As a combination product whose primary mode of action is a drug the product would be reviewed by CBER.