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

Antibiotics Could Get Double Exclusivity Under House Bill; FDA Makes Its Own Moves

Executive Summary

Five years of additional exclusivity, priority review and fast-track status are the carrots offered in legislation introduced by Rep. Phil Gingrey, R.-Ga., June 15 to entice drug makers to develop antimicrobials for drug-resistant pathogens.

You may also be interested in...



Orphan Antibiotics? Woodcock Says It May Be Possible If IDSA’s New Pathway Is Implemented

CDER director says SPLMU proposal could open up antibiotics for resistant pathogens to orphan drug incentives, which could help prime the anemic development pipeline.

Antibiotics Stewardship Remains Open Question On Capitol Hill

FDA’s role in the practice of medicine becomes an issue as IDSA’s proposal to spur antibiotic development by coupling small trials with limited use comes late to the antibiotic incentives debate on Capitol Hill.

PDUFA Draft Bill Would Broaden FDA’s Mission, Make Guidance Development More Public

FDA would be tasked with protecting public health while promoting economic growth and job creation under a discussion draft from the House authorizing committee. Draft Guidances would be voided if not finalized within a year under the proposal.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS053500

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