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

GAIN Begins (Part 1): FDA Completes Turnaround On Antibiotic R&D

This article was originally published in RPM Report

Executive Summary

In less than two years, FDA has moved from requiring unrealistic approval standards for antibiotics to exploring innovative ways to shorten the pathway for the most-needed drugs. And, surprise: Congress is on board too. After 15 years, there is finally real momentum on antibiotic drug policy. But is it all enough to get companies back in the game?

You may also be interested in...



US FDA Joins Chorus Of Concerns About Results Of GAIN Act

It's too early to say whether program is working, FDA tell Congress; agency has awarded 147 QIDP designations, but none of 12 approved antibacterals have new mechanism of action.

Better Incentives Needed For Worsening Fungal Infection Threat

The increasing threat of treatment-resistant Candida auris fungal infections suggests the need for greater development incentives, CEOs of three antifungal drug developers told the recent BIO annual meeting.

Anti-Infective Incentives: GAIN, LPAD Won’t Be Enough HHS-Commissioned Report Finds

The continuing government interest in incentives for antibacterial development got a boost from an unexpected quarter in June. A report commissioned by HHS calls for a broad package of incentives to stimulate continued investment in new anti-infectives.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS081095

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