Generics Bulletin is part 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

ANDA Submissions Drop To Start FY2021

Perhaps Forced Down By COVID-19

Executive Summary

First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.

You may also be interested in...



FDA Guides On Bioequivalence Studies And COVID-19

Guidance on protecting participants in bioequivalence studies during the COVID-19 pandemic has been published by the FDA.

New AAM CEO: Traditional Lobbying On Lowering Health Care Costs Can Mix With COVID-19 Talks

Dan Leonard is working on post-pandemic generic drug issues, using coronavirus as a way to get in front of lawmakers.

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

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.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

LL1131980

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