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

Harmonization Fail: ICH Guideline Doesn’t Simplify Safety Reporting, Firms Say

Executive Summary

Crucially, the synchronization of landmark dates and reporting periods seems not to have been resolved by publication of the FDA/ICH document.

You may also be interested in...



Benefit-Risk Assessment Framework Pushes Into Post-Approval Arena

An industry/regulator working group will flesh out the processes involved in the eight-step framework and identify data that can be used at each step, in both the pre-market and post-market stage.

Post-Market Safety Updates Replaced By “Periodic Benefit-Risk Evaluation Reports”

Draft guidance from FDA would adopt the International Conference on Harmonization’s periodic benefit-risk evaluation reports, which will offer sponsors the opportunity to provide updates on benefit information along with safety signals to the regulatory authorities.

Janssen’s Sirturo Needs Minor Tweaks To Confirmatory Trial, FDA Panel Says

Gathering more data to assuage concerns about possibly lower efficacy in black patients will be key to converting the accelerated approval to full approval for the tuberculosis drug, FDA’s Anti-Infective Drugs Advisory Committee concludes.

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS054622

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