Pink Sheet 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

Views Differ On How Lab-Developed Tests Fit In FDA Companion Dx Guidance

This article was originally published in The Pink Sheet Daily

Executive Summary

Some test kit makers say FDA needs to revise the draft issued this summer to state more plainly its intention to require clearance or approval for lab-developed companion diagnostics.

You may also be interested in...



FDA On Personalized Medicine: Don’t Skimp On Diagnostic Quality Development

A Center for Devices and Radiological Health representative tells a conference on drug/diagnostic co-development that it doesn’t matter how well designed a study for a therapeutic agent is if the accompanying biomarker-targeted test is not reliable and uniformly implemented.

FDA: Draft Guidance For Laboratory-Developed Test Regs Taking Extra Time

The head of FDA’s diagnostics office is hopeful that draft guidance governing laboratory-developed tests will be issued by year-end, but cautioned that the process is taking more time than expected.

Cancer-Genomics Firm Quanticel Debuts With Close Ties To Celgene, And An Exit In Mind

Celgene will get exclusive use of Quanticel's single-cell genomic analysis to tweak its clinical pipeline, and it also has exclusive options to acquire the venture-backed start-up.

Topics

UsernamePublicRestriction

Register

PS072929

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