Buying Time: Industry Sacrifices Early To Gain Later With PDUFA V Review Model

01 Oct 2012
News

Derrick Gingery @dgingery derrick.gingery@informa.com

Executive Summary

NMEs and novel biologics will see reviews allotted two additional months under the revised model launching Oct. 1. Industry expects to gain more communication and first-cycle approvals, while FDA hopes it can receive more complete applications at submission and improve transparency.

Already Registered? Sign in to continue reading.

New to Pink Sheet? Start a free trial today!

Table
View full table

Topics

United States

Subjects
Drug Approval Standards

Related Companies

Novartis AG

ASK THE ANALYST
Email

Print
Bookmark
Share

Tags:

BioPharmaceutical United States Drug Approval Standards

You must sign in to use this functionality

Authentication.SignIn.HeadSignInHeader

PS054767

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

PS054767

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.

Buying Time: Industry Sacrifices Early To Gain Later With PDUFA V Review Model

News

Executive Summary

Related Content

Topics

Related Companies

You must sign in to use this functionality

Authentication.SignIn.HeadSignInHeader

Register

Ask The Analyst

Email Article

Sign In To Set a Search Alert