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

UsernamePublicRestriction

Avastin Vs. Makena: A Comparative Timeline Of The Two Accelerated Approval Withdrawal Fights

Executive Summary

The effort to remove Makena from the market has already lasted longer than the Avastin process from initial advisory committee vote favoring withdrawal until the final order, and the Makena appeal hearing hasn’t even been scheduled yet.

You may also be interested in...



User Fee Bill’s Accelerated Approval Reform Provisions Watered Down, But Could Speed Withdrawals

Withdrawal procedure in House consensus bill would require only one advisory committee hearing, instead of potentially two, likely shortening the time to a final decision.

Makena Accelerated Approval Hearing Will Be Virtual, Likely In September Or October

Presiding officer Celia Witten denies Covis’ request for an in-person hearing, saying it is unclear at this time how COVID would affect a proceeding in the fall. Hearing agenda spans two-and-a-half days and is modeled, in part, on the Avastin hearing, but with twice the time for public comment.

Sen. Wyden Using Califf Nomination To Extract Accelerated Approval Reforms

The unexpectedly tight fight to get Robert Califf confirmed as FDA commissioner is giving lawmakers additional leverage to extract commitments. However, the Senate Finance Chair may be overestimating FDA’s ability to swiftly pull accelerated approvals without new legislation.

Related Content

Topics

UsernamePublicRestriction

Register

PS145544

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