Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

FDA Inspections Ombudsman Could Help Foreign Manufacturers

Executive Summary

New ORA position intended to help get questions answered, but already being used to smooth inspection issues.

You may also be interested in...



US FDA’s New Compliance Chief Donald Ashley Brings International Law Enforcement Experience

Ashley's many years in the Department of Justice’s Office of International Affairs should be a plus for agency's globalization efforts.

Despite Globalization, Three Quarters of Serious Inspection Issues FDA Found Were in US

Interactive map, charts provide details on our analysis of FDA 2009-2014 inspection results data showing that even as the agency responded to the threat of poor drug quality abroad, it was more successful at finding serious quality issues during its much more numerous domestic inspections.

GDUFA II: Inspection Information Takes Center Stage

Sponsors say transparency is important as generic drug user fee negotiations move to inspection policy.

Related Content

Topics

UsernamePublicRestriction

Register

MT101489

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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