HBW Insight 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 Explores Pandemic Inspection Alternatives, Post-Pandemic Strategies

Executive Summary

Agency's Janet Woodcock  and Judy McMeekin say the FDA is looking at options like livestream plant videos while preparing to address backlog after inspections can resume.

You may also be interested in...



US FDA's On-Time Review Decision Rates Slip During The Pandemic, Especially For Biosimilars

Likelihood of an on-time decision on a biosimilar application dropped significantly during the first nine months of the pandemic and declined a bit for new and generic drug applications. FDA says BsUFA review performance is function of program's small sample size.

US FDA Needs Plan For Addressing Inspection Backlog Post-COVID, GAO Says

Agency must plan to ensure that a growing backlog of surveillance inspections does not impede its ability to conduct inspections at high-risk sites, GAO official says.

Preparing For The Return Of US FDA Inspections

FY2020 review highlights drop in inspections, preparations for growing backlog, and pandemic test of Janet Woodcock’s 21st Century proposition – developments that will likely reverberate in the years ahead.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

RS151160

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