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 Communications Are Not Crisis Management Tools, FDA Says

Executive Summary

A new draft guidance explains the Center for Drug Evaluation and Research’s approach to communicating emerging drug safety information. Since 2010, Drug Safety Communications have replaced a variety of audience-focused tools laid out in a 2007 guidance, but FDA says public health alerts will be used to communicate about products that pose an immediate danger.

You may also be interested in...



Drug Safety Communication “Close Out” Process Sought By BIO

FDA’s plan to permanently archive old safety communications, even after an issue has been resolved, is not aligned with the goal of informing the public about potential emerging risks, the Biotechnology Industry Organization says in comments on a recent draft guidance. Pharmacy groups want the agency’s safety communications to include more information about the data underlying a potential risk.

CDER To Pilot Test New Framework For Classifying Drug Safety Issues

A recent draft guidance spells out the agency’s proposed approach to classifying significant post-marketing safety concerns for “standard,” “priority” or “emergency” handling. After pilot testing the framework over the next year, CDER intends to develop milestones for regulatory action on safety issues, similar to NDA/BLA action dates under PDUFA.

CDER To Pilot Test New Framework For Classifying Drug Safety Issues

A recent draft guidance spells out the agency’s proposed approach to classifying significant post-marketing safety concerns for “standard,” “priority” or “emergency” handling. After pilot testing the framework over the next year, CDER intends to develop milestones for regulatory action on safety issues, similar to NDA/BLA action dates under PDUFA.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS054315

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