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

UsernamePublicRestriction

Drug Safety’s “Equal Voice” To Be Considered At Internal CDER Workshop

Executive Summary

Review staff from the Center for Drug Evaluation and Research will meet in December to discuss how to implement the concept of giving an "equal voice" to safety personnel during regulatory decision-making

You may also be interested in...



CDER Eyes Prioritization, Timely Resolution Of Post-Marketing Safety Issues

Now that it has a system in place to track post-marketing drug safety issues, FDA’s Center for Drug Evaluation and Research is turning its attention to setting standard timeframes for investigating and addressing such signals.

CDER Eyes Prioritization, Timely Resolution Of Post-Marketing Safety Issues

Now that it has a system in place to track post-marketing drug safety issues, FDA’s Center for Drug Evaluation and Research is turning its attention to setting standard timeframes for investigating and addressing such signals.

The REMS Report Card: FDA Using New Tools For One-Third Of New Drugs In First Six Months

FDA has used its new authority to impose a Risk Evaluation and Mitigation Strategy on roughly one-third of all new molecular entities approved since the REMS provisions of the FDA Amendments Act took effect at the end of March.

Related Content

Latest News
See All
UsernamePublicRestriction

Register

PS050170

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