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

Top FDA Officials Warn About Non-Vetted Pharmacogenetic Tests After Latest 23andMe Approval

Executive Summary

A day after 23andMe gained US FDA go-ahead for a DTC genetic test service to inform patients about their ability to metabolize medications, the agency issued a safety communication, paired with a joint statement from device- and drug-center heads, warning consumers against trusting genetic tests that have not been vetted by FDA.

You may also be interested in...



Virgin Group Fund Elevates 23AndMe $3.5Bn IPO

23andMe is teaming up with blank check company VG Acquisition Corp to go public, making the move into personalized health care.

23AndMe To Go Public At $3.5Bn With Sir Richard Branson-Backed SPAC

23andMe is teaming up with blank check company VG Acquisition Corp to go public, making the move into personalized health care.

Petition Argues FDA Has Overstepped In PGx Regulation

A group of manufacturers and clinicians is asking the US agency to allow more discussion between manufacturers, labs and clinicians of how genetic factors could influence drug effectiveness  an area known as pharmacogenomics (PGx). The FDA had previously taken several steps to limit these communications.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

MT123521

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