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

Remote Site Visits Will Help US FDA Keep Reviews On Track As Pandemic Constraints Continue

Executive Summary

Guidance discusses what are generically called virtual inspections, but which the agency terms “remote interactive evaluations.” As site inspections remain constrained by the pandemic, remote interactive evaluations “should help FDA operate within normal timeframes,” the document says.

You may also be interested in...



In Second Term At Helm, Would Califf Steer US FDA On Supplement Market Regulation Changes?

CRN and NPA are receptive to former FDA Commissioner Robert Califf’s potential return to the post. NPA says his previous comments on FDA’s authority is a good sign he may help act on supplement industry issues stalled within the agency in recent years.

Records From Down Under Put Personal Care Product Provider Under US Regulatory Thumb

FDA’s remote assessment using documents Natural Beauty Care Pty provided led to a warning and an import alert. Melbourne area contract manufacturer responded to FDA request in April 2020, soon after agency stopped international inspections due to the coronavirus pandemic.

US FDA Gets Less FY2022 Funding From Senate Than House, Different Inspection Priorities

CDER would receive $17m less in Senate appropriations bill compared to House veion, while CFSAN's total would be nearly $10m less. Overall,  Senate bill includes around $50.4m less in funding for FDA than House bill.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

RS151228

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