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

UsernamePublicRestriction
UsernamePublicRestriction

Biosimilars: Next User Fee Cycle Will Be Judged On US FDA's Approvals, Rep. Burgess Says

Executive Summary

Chair of the House Energy and Commerce Health Subcommittee expects BsUFA II also to be judged on FDA's review process predictability.

Advertisement

Related Content

US Biosimilars: 40% First-Cycle Approval Rate Leaves Room For Improvement
US FDA Commissioner Confirmation: Gottlieb To Get Questions On Approval Standards, Ties To Industry
CDER Director Woodcock Plans Changes To Drug Reviews During OND Transition
US Generic Reviews: Would Pre-Submission Meetings Be Better Than Six-Month Priority Review?
Pending Biosimilars
FDA Gets Broad Exemptions From Federal Hiring Freeze In HHS Memo
Biosimilars Will Get PDUFA-Style Reviews Under New User Fee Plan
Biosimilar User Fee Agreement Offers FDA Funding Boost, Fee Structure Overhaul
Biosimilar Interchangeability May Be Losing Luster As Approval Goal
Show Me The Money: Salaries, Red Tape Challenge FDA Recruiting

Topics

Advertisement
UsernamePublicRestriction

Register

PS120234

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

All set! This Question has been sent to 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