Pink Sheet is part of the Business 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


FDA Compliance Office Wants To Find Clinical Trial Problems In Time To Correct Them

Executive Summary

The agency is seeking a quality-by-design approach to clinical trials so sponsors can identify potential risks to patient safety and trial implementation up-front and take steps to avoid them.


Related Content

Clinical Trial Monitoring Not Ready To Go Completely Off-Site, FDA Says
FDA Urges Centralized Clinical Trial Monitoring Over Frequent On-Site Visits - Guidance
Public/Private Initiative To Help FDA Modernize Guidance For Clinical Trials





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