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


FDA Safety Data-mining In Literature To Start With Fluoroquinolones, Lipid Drugs

This article was originally published in The Pink Sheet Daily

Executive Summary

The agency is seeking a contractor to develop a tool to examine the National Library of Medicine’s MEDLINE database of biomedical articles, with pilot studies that seemed aimed at quantification of already-know risks.

You may also be interested in...

Fluoroquinolones To Get “Better” But Not Necessarily Stronger Warning On Nerve Damage

Risk of peripheral neuropathy is already in labeling and FDA doesn’t want to require a black box, illustrating the agency’s ongoing challenge to fully communicate risks without unduly limiting access or use.

Fluoroquinolone REMS Will Survey Patients, Doctors on Understanding of Risk

FDA's risk evaluation and mitigation strategy for fluoroquinolone antibiotics requires manufacturers to survey patients and prescribers to make sure they understand the risks of tendon injury associated with the products

Crestor Adverse Events Comparable to Zocor In Statin Safety Report

AstraZeneca's Crestor falls in the middle of the statin pack in terms of class-related adverse events in actual practice, according to preliminary results of a claims database analysis by the National Lipid Association





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