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

FDA REMS Platform Will Make Safety Plans Easy – Maybe Too Easy?

This article was originally published in The Pink Sheet Daily

Executive Summary

There is concern that common software package could mean more drugs end up with risk management programs.

You may also be interested in...



REMS Standardization Could Help Opioid Education Efforts

FDA hopes to begin accepting Risk Evaluation and Mitigation Strategy documents in structured product labeling format later this year.

PDUFA VI: BIO Survey Finds FDA Communication Problems

Data may help industry stake out its negotiating position as formal talks near for user fee reauthorization.

FDAAA Fading? REMS Use Continues To Decline As Drug Safety Law Matures

FDA’s use of REMS continues to fall to almost undetectable levels, with the agency using the safety tools just a handful of times in the sixth full year of the program. REMS are now very much the exception and not the rule for new products – but still a very important exception.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS077963

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