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

Break-Point: FDA Committee Votes To Restrict Quinolones, But Does Not Endorse Disability Syndrome

This article was originally published in RPM Report

Executive Summary

An FDA advisory committee review of quinolone antibiotic safety focused on a very old safety issue – but points to a new era in antibiotic development, and restricted use models.

You may also be interested in...



Diagnosing A Healthy US FDA: The MRI Drug Safety Review

Do MRI contrast agents cause debilitating chronic illnesses in some patients who receive them? A group of patient advocates firmly believes they do. FDA’s approach to addressing the risk via a public advisory committee shows the agency has found an effective way to handle the type of safety scare that could have paralyzed it a decade ago.

A Final Push For US Hepatitis C Eradication Plan In 2024

The Biden Administration is hoping that it can attach funding for a national hepatitis C ‘subscription’ program into the delayed fiscal 2024 appropriations bills.

Menopausal Status Is Another Focus For US FDA Trial Inclusion Efforts

US FDA is emphasizing the need to assess the effects of menopause on drug safety and efficacy as a continuation of the agency’s efforts to encourage clinical trial sponsors to look more systematically for differences in clinical trial subpopulations.

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS079793

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