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


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

Executive Summary

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.

You may also be interested in...

FDA Safety Labeling Change Guidance Seeks To Ease Class Confusion

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.

When Is An Adverse Event Not An Adverse Reaction?

Misclassifying adverse events and adverse reactions is a major source of error on drug labels, Leander Fontaine, former head of labeling at Wyeth, said.

Industry Seeks Power To Trigger Safety Labeling Changes Under FDAAA

Seeking to turn the regulatory burdens imposed by the FDA Amendments Act to their advantage, pharmaceutical manufacturers are asking the agency to give sponsors the power to trigger safety-related labeling changes under the statute.

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