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Antibiotic Development: US FDA Needs Draft Guidance On QIDP Designation, GAO Says

Executive Summary

Sponsors lack comprehensive advice on how to access benefits of GAIN legislation's incentives, which include the opportunity for fast track designation, priority review designation and five years of market exclusivity, government watchdog says.

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.

US Antibiotic Incentives Extended To Drugs That Prevent Or Diagnose Infections

Law defines QIDP as antibacterials and antifungals intended to 'treat' serious infections, but FDA now interprets provision more broadly to include preventive and diagnostic products, agency says in a new draft guidance clarifying program's requirements and benefits for sponsors

Antibiotics Pipeline Is Lively, But Sponsors Are Fragile

Regulatory uncertainty could imperil the crop of emerging companies making a go of it in the incentive-laden US anti-infective space.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS120158

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