Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

FDA Ends ANDA 'Reviews' To Streamline Approval Process

Executive Summary

Instead, US agency will conduct 'assessments' of generic drug applications, according to new MaPP.

You may also be interested in...



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

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

Gottlieb Leaves FDA Feeling Good About Generic Approvals, But Concerned About Innovative Competition

In interview with the Pink Sheet, US FDA Commissioner Scott Gottlieb offers a final reflection of his time as commissioner.

Gottlieb Uses ASCO Platform To Unveil Two Pilot Programs To Speed Drug Review

US FDA commissioner outlines plans to allow partial submissions as soon as database locks and to create joint sponsor-agency review documents.

Related Content

Topics

Latest News
UsernamePublicRestriction

Register

PS122235

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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