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

FDA Clears Drugs With Post-Market Safety Questions Faster Than It Re-labels

Executive Summary

FDA's "1early communication" program for alerting the public about potential drug safety issues produces a clean bill of health for products about 40 percent of the time, according to an analysis by "The Pink Sheet." And those positive decisions come much quicker than labeling changes the program has produced for drugs where genuine concerns have emerged

You may also be interested in...



FDA’s “Early Communication” On Pancreatitis Risk For Incretin Mimetics Draws Clinician Ire

The agency announces that it is evaluating unpublished findings based on pancreatic tissue specimens from a few deceased patients; clinicians say ongoing prospective studies will determine how diabetes drugs affect the pancreas.

Zyvox Drug Interactions Draw Second Safety Communication From FDA, But Pfizer Says Info Isn't New

FDA and Pfizer appear to disagree over whether new information about harmful drug interactions between Pfizer’s antibiotic Zyvox (linezolid) and serotonergic antidepressants, including multiple deaths, led the agency to issue a drug safety communication.

Zyvox Drug Interactions Draw Second Safety Communication From FDA, But Pfizer Says Info Isn't New

FDA and Pfizer appear to disagree over whether new information about harmful drug interactions between Pfizer’s antibiotic Zyvox (linezolid) and serotonergic antidepressants, including multiple deaths, led the agency to issue a drug safety communication.

Related Content

Topics

UsernamePublicRestriction

Register

PS051647

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