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

Antibiotic Susceptibilty Re-labeling Increases FDA Susceptibility To New Political Challenges!

This article was originally published in RPM Report

Executive Summary

The FDA faces a difficult, legislatively-mandated requirement in the anti-infective area. It is charged with updating antibioitic susceptibility charts in labeling for all approved anti-infectives. That is a huge task -- almost equivalent to re-reviewing the large cadre of existing antibiotic drugs. To try to achieve the task, the agency has proposed trusting an outside standards group for help. That sounds like a practical solution; but Capitol Hill has political problems.

You may also be interested in...



Antibiotic Development: Where Wall Street Guidance Is Watching FDA Guidances

FDA’s effort to create a clearer path for antibiotic development has produced a series of new guidance documents. Those guidances are making some products in development look well-positioned for regulatory review, and rekindling the interest on Wall Street in specialty antibiotic firms.

Forest Labs Had Effective "Co-Sponsor" for Ceftaroline Review

FDA got a chance to show off its ability to stimulate antibiotic development during an advisory committee review of a new cephalosporin from Forest Labs. In the past, the agency has been faulted for failing to set clear targets for anti-infective trials; with ceftaroline, the agency went to the other extreme, stepping in to support an application with key re-analyses of data.

FDA Catching Antibiotic Incentive Bug: Agency Primed To Consider Ways To Shorten Route for Resistant-Strain Drugs

FDA is working along a parallel path to other several other government agencies to find ways to stimulate drug development for anti-infectives active against resistant strains. Top policy leaders in the drug review divisions reflect the new interest by thinking aloud how historical controls or oncology-like accelerated approvals might speed the process.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS080636

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