Pink Sheet 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

US FDA's Digital Health Plan Could Brighten OTC Device Outlook

Executive Summary

FDA says its "traditional approach" for hardware-based medical devices of moderate and higher risks "is not well suited for the faster iterative design, development and type of validation used for software-based medical technologies. Digital technologies such as mobile apps likely will have a role in facilitating additional Rx-to-OTC drug switches.

You may also be interested in...



Drug/Software Combo Pathway Coming Soon To US FDA, Gottlieb Says

Under a new regulatory platform, drugs could soon be approved with accompanying software applications that could monitor adverse events or patient compliance without a separate pre-market device review.

Drug/Software Combo Platform Coming Soon To US FDA, Gottlieb Says

Under new platform, drugs could soon be approved with accompanying software applications that could monitor adverse events or patient compliance without a separate premarket device review.

Innovation In OTC Switches Takes Multimedia Approach In US FDA Draft Guidance

Sponsors can point consumers to video displays, website information and mobile apps to help them choose products that have been switched from Rx to OTC. Draft guidance on innovative switch applications to be followed by rule-making in near future.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS123783

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