FDA “Breakthrough Therapy” Designations

This article was originally published in Pharmaceutical Approvals Monthly

30 Jul 2014
Analysis

Executive Summary

Breakthrough status was introduced in FDASIA to facilitate development and review of drugs to treat serious/life-threatening diseases where there is early evidence of a substantial improvement over existing therapies.

Already Registered? Sign in to continue reading.

New to Pink Sheet? Start a free trial today!

Table
View full table

Topics

Industries
BioPharmaceutical
Regions
North America

United States

Subjects
Regulation

ASK THE ANALYST
Email

Print
Bookmark
Share

Tags:

BioPharmaceutical United States Regulation

You must sign in to use this functionality

Authentication.SignIn.HeadSignInHeader

PS005766

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

PS005766

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.

FDA “Breakthrough Therapy” Designations

Analysis

Executive Summary

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