Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

IOM On “Omics” Assays: Stricter Controls Are Needed For Development Process

This article was originally published in The Gray Sheet

Executive Summary

The Institute of Medicine recommends a highly controlled, step-wise approach to bringing complex genomic, proteomic and similar assays from basic research to clinical testing. FDA needs to play a central role, IOM stresses in a recent report.

You may also be interested in...



FDA Agrees To Waive User Fees For Reviews Of Lab-Developed Tests

Although FDA is still developing its lab-developed test regulatory framework, it has agreed not to collect user fees to support its planned review of the tests.

Abbott Capitalizes On Pandemic Testing Boom; Device Sales Stay Almost Flat

Abbott reported almost 28% revenue growth in the fourth quarter led by the exploding demand for COVID-19 tests and continued success of its FreeStyle Libre continuous glucose monitor.

Agios’ Mitapivat Shows Improvement In Regularly Transfused PKD Patients

While representing a smaller population, the ACTIVATE-T trial targeted patients seen as having greater unmet need.

Topics

UsernamePublicRestriction

Register

OM005224

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