Pink Sheet is part 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


Critical Path follow-on biologics projects idle

Executive Summary

FDA Chief Medical Officer Janet Woodcock says there is little interest by industry in follow-on biologics projects under the Critical Path Initiative. "I don't think that we've gotten a lot of partners to work on those different projects, they are not very prominent," she observes. The agency's opportunities list includes two projects - Novel Approaches to Characterizing and Standardizing Biological Products and Enabling Manufacturing Changes for Well-Characterized Proteins - that could clarify underlying scientific issues complicating development of regulatory policy on follow-on biologics (1"The Pink Sheet" April 10, 2006, p. 13)...

You may also be interested in...

FDA Sees Critical Path Opportunity To Address Follow-On Biologics

FDA's Critical Path opportunities list suggests that the agency is actively working to lay the scientific groundwork for follow-on biologics

Coronavirus Pipeline: GSK And Clover Add To Collaborations

Companies continue to throw their hats into the ring against the virus, with strategies ranging from ‘off the shelf’ molecules to novel vaccine and anti-viral therapies

Switzerland And UK Work On Closer Medtech Ties As EU Links Fall Apart

Switzerland’s current economic and trading relationship with the UK is based on its MRA with the EU. So, where does this leave the two countries in trading with one another now each of their relationships with the EU are under threat?




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