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

UsernamePublicRestriction
UsernamePublicRestriction

Whose Burden Is It Anyway? REMS’ Health Care Impact Belongs To FDA, PhRMA Says

Executive Summary

Industry group contends that FDA should assess whether a REMS places an undue burden on the health care industry – because asking companies to do that evaluation would be an additional burden on the health care system.

You may also be interested in...



Postmarket Data Tops FDA’s Research Wish List In Safety Self-Assessment

Industry must weigh value of strengthening agency’s armamentarium as FDA continues to seek outside collaborations in follow-up to 2011 publication.

REMS Communications Need FDA Logo To Boost Doctors’ Attention, Advisors Say

Risk Communication Advisory Committee suggests that adding the agency imprimatur to REMS materials may help distinguish it from promotional mail and ensure providers read the communications.

REMS Communications Could Get Refreshed After Advisory Panel Meeting

FDA’s Risk Communications Advisory Committee will address methods for presenting REMS information and assessing whether it is reaching the target population.

Related Content

Topics

UsernamePublicRestriction

Register

PS055543

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