Pink Sheet 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

Seven Days In March: NDA-BLA and ANDA Approval Output Diverged As Coronavirus Teleworking Began

Executive Summary

New drug approvals dropped, likely because of a new focus on COVID-19 treatments, while generic drug approvals increased.

You may also be interested in...



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.

Generic Drug Approvals Still Winning The Pandemic At US FDA

Productivity remains high as full ANDA approvals reached a FY 2020 peak and complete responses dropped to another low in June.

COVID-19 Demands Merit A Mention In US FDA's PDUFA Fees Notice For FY 2021

The pandemic's impact was mentioned only in FDA's calculations for fees including those established by PDUFA. In addition to prescription drug applications, PDUFA fees are charged for OTC switch applications and other proposals for ingredients that are not part of an OTC monograph to be made available nonprescription.

Related Content

Topics

UsernamePublicRestriction

Register

OM000882

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