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

One-Page Patient Medication Information Document Moves Forward Under Proposed Rule

Executive Summary

After decades of work, the US FDA released proposed requirements for a simplified version of the Medication Guide for all products. Electronic distribution in lieu of paper ‘upon a patient’s request’ would be allowed. Comments sought on the value of consumer testing of the documents.

You may also be interested in...



Third Time’s A Charm? US FDA Once Again Proposes Mandatory Consumer Rx Info

The US Food & Drug Administration is once again proposing a mandatory summary of key labeling information be dispensed with every prescription drug. Will the idea stay on the books this time?

House Appropriators Warn US FDA: Stop Working On Electronic Labeling Rule

Congress is 'very concerned' about potential final rule that would move to electronic labeling in lieu of paper distribution with prescriptions.

US Patient Medical Information Rule: Will It Be Delayed Again?

FDA originally proposed mandatory patient labeling in 1980 only to have the rule withdrawn by the incoming Reagan Administration; thirty-five years later, US agency is finalizing a proposed rule on the same topic. Will history repeat itself?

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS148298

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