Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FDA Turns Down Sensor-Embedded Tablet For Monitoring Medication Adherence

Executive Summary

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.

You may also be interested in...



First ‘Digital Medicine’ Approved, Slow Rollout Planned

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.

FDA Guidance Sheds Light On Human Factor Studies For Combo Products

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 In response, the agency has issued a draft guidance.

Texas To Tokyo: Japan Darvias Approval Marks End Of Long Development Road

Solasia's arsenical drug darinaparsin has received its global-first approval in Japan, for PTCL, in a landmark for the Texan chemist who discovered it back in the 70s and paving the way for wider indications and Asian markets.

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

MT036025

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel