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 Explains How It Is Embracing Remote Assessments Post-Pandemic

Executive Summary

Agency provides additional details on plans for various remote methods of assessing Rx and OTC drug manufacturing facilities that became popular when investigators were prevented by COVID-19 travel restrictions from visiting sites in person.

You may also be interested in...



Eager But Wary: Industry Seeks More Useful, More Detailed Remote Regulatory Assessment Processes

Responses to FDA draft guidance suggest more promptness while also more elaborate processes for agency decision making based on remote methods. Questions include what’s voluntary, what’s mandatory, what can be decided remotely, and how to remotely move on from warning letters.

US FDA Touts Benefits From Remote Assessments, Manufacturers Feel Burden – Trade Groups

CHPA members’ feedback on RRAs indicate that “time and resources saved by FDA do not translate to time saved by the manufacturer.” CRN suggests FDA “clearly identify the purpose of the RRA in its initial request and limit requested documents to only those directly related to the purpose of the RRA.”

Remote Assessments A Welcome Option For US FDA, But They’re Not Every Firm’s First Choice

“We're looking to expand the use of this tool make it a more routine part of our operations going forward,” says Michael Dutcher, deputy director, ORA Office of Human and Animal Food Operations. “In general, the response from industry has been pretty positive” about RRAs.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS152752

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