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

FDA Antibiotic Task Force Developing Standards To Help Products GAIN Traction

This article was originally published in The Pink Sheet Daily

Executive Summary

Task force model emerging as agency’s standard approach to implementing statutory directives to enhance product development.

You may also be interested in...



Antibiotic Resistance Gets Attention Of FDA, Congress

Both FDA and Congress are taking interest in combating antibiotic resistance, but FDA likely has more power to make headway in the near term, even as industry remains somewhat wary of that particular agenda item.

Antibiotic Exclusivity: Which Vision Will GAIN Upper Hand In FDA List-making?

Industry presenters tell FDA a broad list of potential diseases will attract more developer interest, but advocacy groups push for more targeted criteria during a public hearing on the new exclusivity incentive.

GAIN Hearing Will Help FDA Set Pathogen List

The agency is seeking comments on the criteria prescribed in FDASIA and suggestions for other standards necessary to create a list of pathogens that qualified infectious disease products should target.

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS074683

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