Generics Bulletin 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


FDA Postpones Foreign Inspections Due To Coronavirus Outbreak

Critical Inspections Will Be Considered Case-By-Case

Executive Summary

The US FDA is postponing “most foreign inspections” through April as a result of the coronavirus outbreak, because it will temporarily not be able to physically inspect foreign produced FDA-regulated products or manufacturers. However, inspections outside the US deemed as critical “will still be considered on a case-by-case basis.”

You may also be interested in...

Viatris And Biocon’s US Bevacizumab Hit By Indefinite Delay

Viatris and partner Biocon have seen FDA action on their application for a bevacizumab biosimilar rival to Avastin delayed by the need for a facility inspection, the timing of which is uncertain due to coronavirus-related restrictions.

FDA Guides On COVID-19 Obstacles To ANDA Studies

Specific guidance for ANDA sponsors on bioequivalence studies during the COVID-19 pandemic has been published by the US FDA.

FDA Scales Back Domestic Inspections Due To Coronavirus

After postponing foreign inspections, the US FDA has further decided to scale back domestic inspections due to the coronavirus outbreak.


Latest Headlines
See All



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