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

Woodcock's Prophesy Comes True: US FDA ANDA Approvals Decline From Record Levels

Executive Summary

Janet Woodcock’s 2019 prediction that record ANDA approval volumes would not continue is confirmed with the FY 2020 approval total down 21% from the previous year.

You may also be interested in...



Closing The Books On GDUFA II

Approval and submission data indicate steady trends aside from one outlier year.

Closing The Books On GDUFA II: How Generics Fared At US FDA Over The Last Five Years

Approval and submission data indicate steady trends aside from one outlier year.

Next US FDA Generics Leader Must Have ‘Frank Conversations’ With Colleagues, Industry, Former OGD Director Says

Susan Rosencrance, who helped negotiate GDUFA III, will take over as acting director of the Office of Generic Drugs following Sally Choe’s departure on 8 October. Former OGD head Uhl says the director needs to be the ‘number one advocate for the generic drug program inside the agency.’

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS143132

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