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

When Is An Adverse Event Not An Adverse Reaction?

Executive Summary

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

You may also be interested in...



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.

Janssen’s Sirturo Needs Minor Tweaks To Confirmatory Trial, FDA Panel Says

Gathering more data to assuage concerns about possibly lower efficacy in black patients will be key to converting the accelerated approval to full approval for the tuberculosis drug, FDA’s Anti-Infective Drugs Advisory Committee concludes.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS053826

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