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

One-Page MedGuide For Long-acting Opioids Sets Stage For Retooling MedGuide Format

Executive Summary

The single-page format could serve as a template as FDA tries to simplify patient information that accompanies prescription drugs.

You may also be interested in...



Opioid Abuse-Deterrent Formulations Could Become Prerequisite To Approval

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee recommends against approval of Zogenix’s Zohydro ER as it seeks safer formulations and stricter REMS for all extended-release/long-acting opioids.

Oral Contraceptive Labeling Likely To Become More Graphic

FDA is nearing completion of guidance on labeling for combined oral contraceptives with an eye toward improving communication with more visual presentations rather than relying on prose.

Opioid Prescriber Knowledge Assessment Due Year After Patient Assessment

REMS assessment schedule for the long-acting/extended release opioid products reflects the large number of drugs, prescribers and patients involved in the risk management program and the time needed to put all its components in place.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS054596

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