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

How The US FDA Finds Pre-Approval Inspection Alternatives During COVID-19 Pandemic

Executive Summary

Officials explain how remote record reviews, site transfers and other factors can green-light approvals of drugs and biologics.

You may also be interested in...



As Pandemic Delays Reduce PDUFA Revenues, US FDA Slows Fee-Related Spending

Agency cites “unexpected and large drop in collections” in slashing user-fee-setting contract.

It Was Inevitable: FDA Inspection Delay Postpones BMS’s Liso-Cel Approval

Bristol Myers Squibb confirmed that approval for lisocabtagene maraleucel (liso-cel) will be delayed by the US FDA’s COVID-19-related restrictions on travel for manufacturing facility inspectors.

Complete Response Letters In Lieu Of Inspections: What To Expect During COVID-19

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS142552

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