FDAAA Impact Analysis (Year 7): The Era of the “Breakthrough” REMS

This article was originally published in RPM Report

01 Sep 2015
Analysis

Michael McCaughan @RPMReportMike michael.mccaughan@previsionpolicy.com

Executive Summary

FDA continues to use the formal Risk Evaluation & Mitigation Strategy authority very infrequently in the context of new drug approvals. There is one countervailing trend: the agency is imposing mandatory communication plans for some of the new oncology therapies – including two “Breakthroughs.”

Already Registered? Sign in to continue reading.

New to Pink Sheet? Start a free trial today!

Table
View full table

Topics

Industries
BioPharmaceutical
Subjects
Risk Management

Related Companies

ASK THE ANALYST
Email

Print
Bookmark
Share

Tags:

BioPharmaceutical Risk Management

You must sign in to use this functionality

Authentication.SignIn.HeadSignInHeader

PS079774

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

PS079774

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.

FDAAA Impact Analysis (Year 7): The Era of the “Breakthrough” REMS

Analysis

Executive Summary

Related Content

FDAAA Fading? REMS Use Continues To Decline As Drug Safety Law Matures

Carving REMS Out of Oncology? FDA, ASCO Plan Follow-Up Workshop

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