Pink Sheet 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

Unannounced Foreign Drug Inspection Pilot, Other US Inspection Measures Enacted

Executive Summary

A suite of pharmaceutical inspection measures stripped from the user fee renewal legislation were added to the US FY 2023 spending law, including provisions for new inspection priorities, remote alternatives, mutual reliance, internal FDA coordination and unannounced foreign inspections.

You may also be interested in...



US FDA Begins Implementing New User Fee Programs, But What About The Actual Fees?

Sponsors looking to file applications continue to wait for the new user fees to be announced, as details of the Split Real-Time Application Review (STAR) program, generic drug facility inspection readiness requirement and other changes are revealed.

House User Fee Bill’s Inspections Provisions Would Add Layers Of Scrutiny Abroad

Inspection subsection would penalize high-quality sites in low-quality foreign regions with greater inspection frequency, while adding more surprise inspections and requiring greater internal US FDA coordination to prevent quality issues from causing drug shortages.

Decorating The 'Christmas Tree’: US House Bills That Could Be Tacked Onto FDA User Fee Legislation

Measures aimed at spurring biomedical innovation, ensuring fewer roadblocks to development of biosimilars and generics, and strengthening the FDA’s interactions with rare disease patients could find their way into must-pass legislation reauthorizing the human drug and biologic user fee programs by 30 September.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS147547

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