Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Accelerated Approval Standards Will Be Advisory Committee Topic In March

Executive Summary

FDA is planning an advisory committee meeting to discuss the accelerated approval process for oncologic agents

You may also be interested in...



Accelerated Approval Needs Enforcement Mechanism For Confirmatory Trials

FDA needs to create an enforcement mechanism to ensure that companies with anticancer agents awarded accelerated approval complete confirmatory trials to show actual clinical benefit, the Oncologic Drugs Advisory Committee agreed

Cancer Drug Confirmatory Trials Should Be Initiated Early, FDA Says

FDA is urging sponsors of cancer drugs undergoing accelerated approval to initiate confirmatory studies early to avoid problems in completing trials often seen after approval

Accelerated Approval Needs Enforcement Mechanism For Confirmatory Trials

FDA needs to create an enforcement mechanism to ensure that companies with anticancer agents awarded accelerated approval complete confirmatory trials to show actual clinical benefit, the Oncologic Drugs Advisory Committee agreed

Related Content

Latest News
See All
UsernamePublicRestriction

Register

PS040928

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