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

ODAC Will Have Bigger Role At Avastin Hearing Than Previously Described

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA tells the Oncologic Drugs Advisory Committee it will have a voting role at the two-day hearing, in contrast with CDER's original expectation that the panel would provide advice and recommendations but not vote.

You may also be interested in...



US Accelerated Approval: As Makena Withdrawal Hearing Looms, A Look Back At The Avastin Experience

With the public hearing on Covis’ drug for preterm birth prevention expected in 2022, the Pink Sheet talked to several former FDA officials and advisory committee members about their experiences at the 2011 hearing on withdrawal of Avastin’s accelerated approval for breast cancer.

Genentech, CDER Spar Over Third-Party Views On Avastin Breast Cancer Claim

Disagreements between Genentech and FDA’s Center for Drug Evaluation and Research over the scope of evidence to be allowed at the June 28-29 hearing on Avastin’s breast cancer indication have escalated into a heated debate over the relevance of external views.

Genentech, CDER Spar Over Third-Party Views On Avastin Breast Cancer Claim

Disagreements between Genentech and FDA’s Center for Drug Evaluation and Research over the scope of evidence to be allowed at the June 28-29 hearing on Avastin’s breast cancer indication have escalated into a heated debate over the relevance of external views.

Related Content

Topics

UsernamePublicRestriction

Register

PS072216

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