CDER Medical Policy Council Balances “Breakthrough” Requests With Broader Issues

This article was originally published in Pharmaceutical Approvals Monthly

22 May 2013
News

Sue Sutter @PinkSheetSutter sue.sutter@informa.com

Executive Summary

FDA is seeking public input on cross-cutting policy issues to bring before the senior-level group, which is also facing the challenge of reviewing dozens of “breakthrough therapy” designation requests relevant to CDER-regulated products.

Already Registered? Sign in to continue reading.

New to Pink Sheet? Start a free trial today!

Table
View full table

Topics

ASK THE ANALYST
Email

Print
Bookmark
Share

Tags:

BioPharmaceutical Drug Approval Standards Safety

You must sign in to use this functionality

Authentication.SignIn.HeadSignInHeader

PS005418

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

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 enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel

PS005418

All set! This article has been sent to my@email.address.

All fields are required. For multiple recipients, separate email addresses with a semicolon.

Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.

CDER Medical Policy Council Balances “Breakthrough” Requests With Broader Issues

News

Executive Summary

Related Content

FDA's Combo Products Review Transformation Begins

Senior CDER Management Panel Could Facilitate Novel Therapy Approval

Topics

You must sign in to use this functionality

Authentication.SignIn.HeadSignInHeader

Register

Ask The Analyst

Email Article

Sign In To Set a Search Alert