FDA Turns Down Sensor-Embedded Tablet For Monitoring Medication Adherence
The agency says it needs more information, and especially more usability testing, before it can approve a new drug application on a combination product that integrates Otsuka’s Abilify antipsychotic with an ingestible sensor made by Proteus, intended to improve medication adherence.
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FDA has approved Abilify MyCite, a treatment for some psychiatric conditions that integrates a drug with a sensor that records when the medication is taken. The goal is to track medication compliance. It is an important regulatory milestone for the nascent field of digital medicine, but many questions about the market remain.
Questions from companies and FDA reviewers about human factor design and data requirements for combination products continue to grow. In response, the agency has issued a draft guidance.
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