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 Allows Broader Indications For Oncology Companion Dx’s

Executive Summary

New guidance from the US agency discusses how manufacturers can pursue broader indications for oncology companion diagnostics. The move could make it easier for clinicians to find the best treatment for each patient.

You may also be interested in...



Cancer IVDs Could See Label Expansions Under New Guidance

US FDA is proposing to allow cancer IVD-makers to label their tests for certain types of cancers and their therapies instead of limiting them to specific drugs and biologics. The agency says the expanded labeling is crucial to giving patients more options and help target treatments.

Guidance Document Clarifies FDA’s Replacement Reagent Policy

The agency allows IVD developers to use assays with different instrument systems without submitting a new 510(k), as long as they meet certain safety and efficacy criteria.

Medtronic Recalls Cardiac Defibrillators Due To Reduced Shock Potential

The device giant is recalling Cobalt and Crome defibrillators because they may deliver weaker shocks than intended.

Topics

Latest News
See All
UsernamePublicRestriction

Register

MT126591

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