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

US FDA’s Coronavirus Workload Shifting Beyond Idea Stage

Executive Summary

Pre-IND inquiries are slowing and the FDA says more late-stage development work is coming.

You may also be interested in...



COVID-19 Supplement Approvals Jump, Some On-Time Decision Rates Slip For US FDA

In FY '21 third quarter, on-time decision rate improved for generics and biosimilars, but dropped again for new drug applications.

The COVID Boom: CBER Receives More INDs in One Quarter Than The Previous 30 Combined

Bubble was short-lived, but still could create workload problems for the US FDA as it navigates the end of the coronavirus pandemic.

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

PS142578

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