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

FDA Met Biosimilar Review Timelines But Missed Meeting Goals In 2015

Executive Summary

Agency's biosimilar meeting workload rose slightly; shifts in types of meetings may reflect maturation of individual biosimilar development programs.

Advertisement

Related Content

US FDA Compliance Strategy: Meetings Replace Some Untitled Letters
Biosimilars Will Get PDUFA-Style Reviews Under New User Fee Plan
Biosimilar Barricade Breached: Amgen Manufacturing Patents Ruled Not Infringed
Biosimilar Advisory Committee Reviews: Necessity Or Nuisance?
Biosimilars Still Flummoxed By Neulasta: Sponsors Now 0 For 2 At FDA
Biosimilar User Fee Talks Begin With Industry Negotiating Amongst Itself
As Biosimilar Meeting Requests Rise, So Do FDA's Performance Goal Challenges

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register