Pink Sheet is part of the Informa Intelligence Division 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

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
Advertisement

Related Content

IRB Handovers Harmonized In Eight-Fold Path Outlined By FDA, OHRP
IRBs Punked Again: FDA Sends Warning Letter To Essex IRB For Approving Fictitious Trial
Single IRB Policy For Multi-Site Trials May Soon Get White House OK; NCI Hopeful
Single IRB Policy For Multi-Site Trials May Soon Get White House OK; NCI Hopeful
Who's Watching The Watchmen This Time? The Mystery Of The New IRB Sting
IRB Check Up: Pediatric Consent Forms Generally Robust, FDA Finds
FDA Stays In Hot Seat On Capitol Hill; PDUFA No Longer Drives Legislation
IRB Problems Will Increase Congressional Pressure On Industry Trial Designs
IRB Problems Will Increase Congressional Pressure On Industry Trial Designs
Legislation On CROs And IRBs Might Be One Fall-Out From Ketek Probe

Topics

Advertisement
UsernamePublicRestriction

Register

PS050969

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

Cancel