Scrip 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 Aims Neglected Tropical Disease Guidance At Inexperienced Sponsors

This article was originally published in PharmAsia News

Executive Summary

Big pharma is not the prime player in the tropical disease area, even as some large firms increase funding.

You may also be interested in...



FDA Adds Three “Qualifying Pathogens” For Potential Antibiotic Incentives

Final rule includes a total of 21 pathogens, but agency notes a drug intended to treat a pathogen on the list is not guaranteed a QIDP designation for priority review and potential added marketing exclusivity.

FDA Cuts Priority Review Voucher Fee By 32%; No Takers For FY 2013

By taking into account the incremental costs of priority review and eliminating the IND aspect of the calculation, the agency reduces the fee to redeem a tropical disease priority review voucher to $3.6 million in fiscal year 2013.

FDA Vaccine Advisors Put Manufacturers On Notice: New Flu Vax Licensing Requirements May Be Coming

The US FDA and its vaccine advisors said manufacturers need to start thinking about the types of studies needed if a major change is made to the quadrivalent flu vaccine by swapping out the B/Yamagata lineage for a second lineage of another flu strain. 

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

SC087618

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. 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