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 Seeks To Write MedGuides Outside REMS Process

Executive Summary

FDA is searching for a way out of imposing a REMS when only a medication guide is required

You may also be interested in...



Gattex Review Shows FDA Approach On MedGuides Outside REMS

FDA said a Medication Guide need not be encompassed within NPS Pharma’s proposed Risk Evaluation and Mitigation Strategy for teduglutide due to the extensive interactions between short bowel syndrome patients and their health care providers and the inclusion of other patient-directed materials.

FDA MedGuide Distribution Guidance May Mean Little Change For Manufacturers

FDA is demonstrating its intent to use discretion in enforcement with a draft guidance aimed at clarifying when Medication Guides must be distributed. However, as a practical matter, pharmaceutical manufacturers may still have to maintain their existing distribution systems for the guides.

FDA MedGuide Distribution Guidance May Mean Little Change For Manufacturers

FDA is demonstrating its intent to use discretion in enforcement with a draft guidance aimed at clarifying when Medication Guides must be distributed. However, as a practical matter, pharmaceutical manufacturers may still have to maintain their existing distribution systems for the guides.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS052342

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