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 Guidance On Substance Use Disorder Supports Medical Device Innovation

Executive Summary

In a 30 August guidance from the US FDA, the agency proposed support and guidance for medical device innovation to treat substance use disorder.

You may also be interested in...



FDA Seeks To Spur Innovation In Devices Designed To Treat Opioid Abuse

Draft guidance from the US Food and Drug Administration provides recommendations for the development of medical devices to treat opioid use disorder and considerations for sponsors of clinical studies to evaluate them.

FDA Committee To Hold Meeting On Genetic Test For Opioid Use Disorder

The FDA will discuss the de novo request for opioid use disorder genetic test, AvertD.

Opioid Approval Standards Could Change Under New US FDA Plan

The Overdose Prevention Framework includes considering whether FDA should require new opioids show superior safety compared to existing products.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT145773

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