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

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...



Is Even The Pharma Industry Over COVID-19 Already?

Data suggests fewer approvals and new product ideas, as the business case for new generic and brand treatments seems to be tougher to make now than at other times during the pandemic.

US FDA Pandemic Performance: On-Time Decision Rates Improve; COVID Applications, Supplements Drop

Biosimilars continue their erratic behavior, with the low numbers driving big swings.

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.

Related Content

Topics

Related Companies

Latest News
See All
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