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

FDA MedGuide Distribution Guidance May Mean Little Change For Manufacturers

Executive Summary

FDA is demonstrating its intent to use discretion in enforcement with a draft guidance aimed at clarifying when Medication Guides must be distributed.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.

You may also be interested in...



Final Guidance Clarifies Distribution Requirements For MedGuides

Final policy on distribution of Medication Guides and inclusion in Risk Evaluation and Mitigation Strategies makes clear what FDA considers a material change.

Eliminating MedGuide-Only REMS Merits PDUFA-Style Deadlines, PhRMA Says

FDA should take no more than three months deciding whether a Medication Guide can be pulled out of an existing Risk Evaluation and Mitigation Strategy, the Pharmaceutical Research and Manufacturers of America believes.

Eliminating MedGuide-Only REMS Merits PDUFA-Style Deadlines, PhRMA Says

FDA should take no more than three months deciding whether a Medication Guide can be pulled out of an existing Risk Evaluation and Mitigation Strategy, the Pharmaceutical Research and Manufacturers of America believes.

Related Content

Topics

UsernamePublicRestriction

Register

PS053180

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