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


FDA Safety Labeling Change Guidance Seeks To Ease Class Confusion

Executive Summary

Final guidance implementing FDAAA authority explains how disagreements between the agency and one or more sponsors could affect the timeline for safety-related labeling changes across a class of products.

You may also be interested in...

Opioid Indication Change Could Draw Legal Challenge From Physicians Group Seeking More Restrictions

FDA tells sponsors to revise the indication for the ER/LA analgesics to highlight appropriate patient selection rather than severity of pain and orders post-marketing studies to identify a dose and duration-of-treatment associated with higher rates of abuse, misuse, addiction, overdose and death.

FDA Labeling Change Rule Is Most Prominent Item On Agency’s To-Do List

HHS’s semi-annual inventory of rulemaking actions under development includes six prescription drug-related rules.

With New Power, New Problems: FDA Confronts Complications of Safety Labeling Change Authority

Drug safety labeling changes that cover large classes of drugs are one of the biggest headaches FDA faces, given its new authority in this area under the Food and Drug Amendments Act, which established a new section 505(o) of the Food, Drug and Cosmetic Act.

Related Content


Latest Headlines
See All



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