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 Issues Co-Development Guidance, But Only For Products Treating "Serious" Diseases

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA Commissioner Hamburg and CDER Director Woodcock outline the requirements for developing drugs in combination during the Faster Cures Partnering for Cures meeting in New York.

You may also be interested in...



Co-Development Guidance Gives More Attention To IND, NDA/BLA Submissions

In a final guidance on co-development of two or more investigational new drugs for use in combination, FDA lays out general principles for IND and marketing application submissions, a topic on which the agency essentially punted in a December 2010 draft document.

Bill Proposes Offering Exclusivity For Novel Drug Co-Development

Bill proposes six months’ extra marketing exclusivity to spur development of combinations of investigational drugs for serious diseases. Setting aside prospects for passage in an election season, the question is whether that will be enough to get pharma to buy into a risky development space and pioneer a new business model.

Right Dosing, Scheduling Key To Anticipating Resistance, Creating Synergistic Combos In Drug Development

The art of developing synergistic combinations of novel drugs that can win the race against resistance mutations was much discussed at the American Association for Cancer Research meeting in Chicago March 31 - April 4.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS071608

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