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

FDA Exploring Limited-Use Approvals For Antibiotics Based On Small Development Programs

This article was originally published in The Pink Sheet Daily

Executive Summary

The agency would like to have a “special medical use” category for drugs, such as antibiotics for bacteria resistant to current therapies, that could be approved based on small trials and whose labeling says they should not be prescribed off-label.

You may also be interested in...



FDA “Limited Use” Approval Pathway Gains Traction in Congress

Sens. Michael Bennet, D-Colo., and Orrin Hatch, R-Utah, signal Congressional revival of the Limited Population Antibacterial Development Program, offering antibiotics as the guinea pig for a potentially broader “limited-use” pathway.

Draft Guidances For 2013 Will Grapple With Biosimilars, Track and Trace, Compounding

FDA’s Center for Drug Evaluation and Research plans to publish more than 50 new and revised draft guidances this calendar year.

Antibiotics For Drug-Resistant Infections Hope To Skip Phase III Trials

PhRMA working group lays out proposal to allow approval of antibiotics for infections constituting an unmet medical need based on open-label studies and observational data.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS073851

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