Pink Sheet 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


IRB Quality Concerns Take Center Stage After FDA Clamps Down On Coast

Executive Summary

Quality has moved up in importance as a criterion for selecting an institutional review board following an April 14 FDA warning letter to Coast IRB and the company's agreement to halt enrollment in clinical studies it monitors

You may also be interested in...

IRB Handovers Harmonized In Eight-Fold Path Outlined By FDA, OHRP

Joint draft guidance on institutional review board switching for industry- and federal government-sponsored clinical trials advances the agencies’ goal creating umbrella coverage in human subject protection.

IRBs Punked Again: FDA Sends Warning Letter To Essex IRB For Approving Fictitious Trial

In an operation highly reminiscent of a government sting three and a half years ago, "Dateline NBC" snares a for-profit IRB using a fictitious protocol.

Single IRB Policy For Multi-Site Trials May Soon Get White House OK; NCI Hopeful

The White House appears close to finalizing a policy that would allow multi-site clinical trials to use only one institutional review board, which National Cancer Institute and other officials think could speed up and improve the process.

Related Content


Latest Headlines
See All



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