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

What Pandemic Effect? US FDA’s 2021 Approval Class Is Off To Strong Start With 60+ Novel Candidates

Executive Summary

Dermatology, chronic kidney disease and liver disease therapies stand out in a crowd of user fee goals that is actually bigger than at the same point in 2020.

You may also be interested in...



Is The US FDA At A Tipping Point?

Wall Street is worried that a cluster of recent negative regulatory events means tougher reviews going forward. That concern is probably overdone, but a year into the COVID pandemic is a good time to take stock of how FDA is doing.

Pandemic Taking Its Toll On The US FDA’s Non-Pandemic Work, Alkermes CEO Says

Last year was not the greatest performance by the agency outside of COVID-19, Richard Pops tells BIO conference.

US FDA Could Be Facing Bolus Of Pandemic-Related Applications

Acting CDER Director Cavazzoni says it is ‘a very active time’ as many clinical trials for COVID-19-related products are expected to read out soon.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS143754

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