Pink Sheet is part of the Informa Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Vocabulary Change: CDER Eliminating 'Review' For NDAs And BLAs

Executive Summary

Like ANDA evaluations, US FDA plans to use the word assessment to describe them for NDAs and BLAs.
Advertisement

Related Content

Sharpless Calls For A Nimble, Flexible, More Efficient US FDA
US FDA's New Development Science Office Modeled On Modeling Office
Four Rules For Being A Consistent US FDA Reviewer From Peter Stein
Reliance On ‘Digitized Paper’ Is Slowing Drug Development – US FDA’s Woodcock
In Switching Generic 'Reviews' To 'Assessments' Is US FDA Changing More Than Just A Word?
FDA Ends ANDA 'Reviews' To Streamline Approval Process
Gottlieb Promotes 'Team' Work For Product Reviews

Topics

Advertisement
UsernamePublicRestriction

Register

PS125086

Ask The Analyst

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 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