Scrip 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

GMP Inspection Results Can No Longer Stay Within Borders, Says U.S. FDA

This article was originally published in PharmAsia News

Executive Summary

Results from manufacturing facility inspections conducted in one country will easily be shared with regulators in another in the near term, says Larry Kessler, U.S. FDA officer and chair of the Global Harmonization Task Force

You may also be interested in...



Global Drug Regulators And Manufacturers Grapple With How To Ensure Global Quality Standards (Part 2 Of 2)

[Editor's note: This is part two of a two-part feature on ensuring drug quality, as discussed at the Fifth IFPMA Asian Regulatory Conference in Kuala Lumpur. Part one appeared in PharmAsia News, March 17, 2008.]

Regulatory Harmonization Takes Center Stage At IFPMA Asia Event

KUALA LUMPUR, Malaysia - Industry and regulators in Asia are mapping out strategies for regulatory harmonization, mostly borrowed from the U.S. and European Union experiences, in an effort to help the rapidly growing Asian pharmaceutical markets

U.S. FDA Move “Beyond Our Borders” Begins With China

Congressional concerns over inspection oversight in the midst of a heparin safety scare have not dampened FDA's efforts to highlight its new overseas initiative, "FDA Beyond Our Borders.

Latest Headlines
See All
UsernamePublicRestriction

Register

SC068230

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. 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