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

Risk-Based Inspections Might Actually Be Hurting Compliant Firms

Executive Summary

Industry exec asks FDA to help good manufacturers prove to other countries they continue to meet GMPs even if they are not inspected frequently.

You may also be interested in...



Review Times Remain A GDUFA II Topic

Talks continue to include ANDA review times and metrics, increasing potential for more changes.

GDUFA II: Inspection Information Takes Center Stage

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

Cheap Drugs Create Quality Temptations, FDA Official Says

FDA will focus on enforcing quality standards, but remains aware of its indirect influence on pricing.

Related Content

Topics

Latest News
UsernamePublicRestriction

Register

PS056971

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