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 Cautions Against Blaming CRLs On Inspection Delays

Executive Summary

Agency revises pandemic inspection guidance to explain CRL ‘non-deficiency’ inspection comments and update industry on remote interactive evaluations and post-COVID-19 inspection priorities.

You may also be interested in...



India’s COVID-19 Surge Forced Another Abrupt Stop Of US FDA In-Person Inspections

Agency inspectors worked in the country for about a month before the coronavirus infection surge forced another halt.

Forty-Eight US FDA Drug Application Decisions Delayed By Pandemic's Deferred Inspections

US FDA 'resilience' report charts how inspection backlog grew and impacted approvals and compliance follow-up. 

Remote Site Visits Will Help US FDA Keep Reviews On Track During Remainder Of Pandemic

Video facility tours expected to help clear way for timely drug and biologic approvals while COVID-19 still prevents inspections.

Related Content

Topics

UsernamePublicRestriction

Register

PS144332

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