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

FDA Considers Using Third-Party Inspectors to Enhance Global Reach

This article was originally published in The Gold Sheet

Executive Summary

FDA is talking about adding an outsourced inspectorate to help it police the globally outsourced pharmaceutical manufacturing industry.

You may also be interested in...



User Fee Bill Puts Industry, FDA to Work on Supply Chain Risks

The user fee legislation Congress approved June 26 makes quality risk management a GMP requirement, further pressuring pharmaceutical manufacturers to make sure they are protecting their global supply chains. The bill directs FDA to inspect based on risk rather than time or location, and to rely on trusted foreign inspectorates, while adding new user fees for generic drugs that will boost funding for further expansion of the agency’s inspectorate.

U.S. Legislative Response to Heparin Crisis Begins to Take Shape

The broad outlines of the timing and scope of a U.S. legislative response to the global pharmaceutical supply chain crisis are taking shape

U.S. Legislative Response to Heparin Crisis Begins to Take Shape

The broad outlines of the timing and scope of a U.S. legislative response to the global pharmaceutical supply chain crisis are taking shape.

Related Content

Latest News
See All
UsernamePublicRestriction

Register

PS000587

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