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


Lab-Developed Tests: FDA Gives Extra Time For Input On Oversight Plan

This article was originally published in The Pink Sheet Daily

Executive Summary

Comments submitted thus far largely do not offer detailed suggestions for alternative regulatory regimes, but highlight particular areas in which the agency should take caution.

You may also be interested in...

FDA Gathers Feedback To Guide Oversight Of Lab-Developed Testing

FDA says it will tailor its future oversight of laboratory tests and services based on risk, but experts warn that "high risk" will be hard to define for these diagnostics

FDA Aims To Finalize Framework For Lab-Developed Tests In Near Term

FDA could have a final framework in place for overseeing a greatly expanded range of laboratory test services within months of a public meeting scheduled for July, according to agency officials

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.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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