Pink Sheet is part 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 Seeks To Write MedGuides Outside REMS Process

This article was originally published in The Pink Sheet Daily

Executive Summary

Agency advice on REMS evolves as FDA gains experience with the program, OSE Director Dal Pan says at DIA.

You may also be interested in...

New Drugs Get "Luck Of The Draw" In FDA's First Round Of 18-Month Reviews

"We're not being surprised by anything we are seeing" in the initial batch of FDAAA-mandated post-market assessments, FDA's Boucher says.

Earlier Attention To REMS Could Keep Drug Approvals On Schedule, Industry Says At FDA Meeting

BIO member survey finds 77 percent of firms with REMS report that risk discussions prolonged product reviews.

REMS Must Be Designed With Input From Doctors, Kaiser Tells FDA In Petition

Kaiser Permanente is pressing FDA to open up the process for creating Risk Evaluation and Mitigation Strategies to a broader audience

Related Content





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