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
UsernamePublicRestriction

NSAID Panel Highlights Challenge Of Getting Comparative Safety Claim

Executive Summary

Does wide public health concern warrant flexibility in regulatory standards for safety claims? Advisory panel on cardiovascular risk of NSAIDs spotlights dual challenge of accurately determining drug risks and communicating risks in informative way.

You may also be interested in...



Pradaxa Medicare Study: Observing a Slow Attitude Change at FDA on Observational Studies

CDER Deputy Director Bob Temple is a confirmed skeptic of the value of observational trial data to FDA’s regulatory decisions. A recent Medicare study on the bleeding risks associated with Boehringer-Ingelheim’s Pradaxa, however, confirmed an earlier position on the drug by FDA and meets with Temple’s approbation.

NSAID Safety Review: FDA Panel Seeks Continued PRECISION From Pfizer

Pfizer’s long-term safety outcome study comparing Celebrex, ibuprofen and naproxen has its flaws, but FDA advisory committee says its data will be far superior to meta-analyses or observational studies.

NSAID Panel Could Give Naproxen Labeling Edge

FDA’s Arthritis and Drug Safety and Risk Management advisory committees on Feb. 10-11 will examine cardiovascular risk data for non-steroidal anti-inflammatory drugs, including meta-analyses indicating naproxen could have a better safety profile than other OTC ingredients ibuprofen and ketoprofen.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS055927

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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