Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

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

This article was originally published in The Pink Sheet Daily

Executive Summary

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

Advertisement

Related Content

Ebola Treatments Could Be Orphan Candidates – But Vaccines, Probably Not
Antibiotic Incentives: FDA’s Woodcock Says LPAD Could Be Better Than Exclusivity, But Questions Remain
Antibiotics Approval Changes GAINing Acceptance; PDUFA May Not Get LPADed Out
ViroPharma’s Failed Exclusivity Bid For Vancocin Could Spur Congress To Act
“Breakthrough” Designation Another Harmonization Opportunity, Woodcock Says
Drug Shortage Senate Draft: FDA Told To Look For Impact Before Leaping Into Enforcement
Antibiotics Stewardship Remains Open Question On Capitol Hill
FDA Antibiotic Legislation Should Focus On Criteria, Not Bacteria, Woodcock Says
Antibiotics Could Get Double Exclusivity Under House Bill; FDA Makes Its Own Moves

Topics

Advertisement
UsernamePublicRestriction

Register

PS073957

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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