EMA, FDA To Address Quality Issues For PRIME/Breakthrough Designation Products

31 Jul 2018
News

Vibha Sharma @ScripRegVibha vibha.sharma@informa.com

Executive Summary

Experience with early access schemes in the EU and the US – i.e., PRIME and breakthrough therapy designation – has shown that sponsors face challenges in complying with quality and manufacturing data requirements.

Already Registered? Sign in to continue reading.

New to Pink Sheet? Start a free trial today!

Table
View full table

Topics

United States

ASK THE ANALYST
Email

Print
Bookmark
Share

Tags:

Europe United States International

You must sign in to use this functionality

Authentication.SignIn.HeadSignInHeader

PS123599

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

PS123599

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.

EMA, FDA To Address Quality Issues For PRIME/Breakthrough Designation Products

News

Executive Summary

Related Content

Real-Time Oncology Review Has Sponsors Rethinking What Data To Share With US FDA And When

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