HBW Insight 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

GSK Consent Decree Includes $650 Mil. Bond, Third-Party Inspections

This article was originally published in The Tan Sheet

Executive Summary

GlaxoSmithKline appears to have negotiated a more favorable consent decree agreement with FDA compared to previous pharmaceutical companies facing similar action

You may also be interested in...



GSK Consent Decree Sets “Aggressive” 150-Day Timeline For GMP Conformity

GlaxoSmithKline's consent decree mandates that the company notify the agency within 150 days of the corrective measures it has taken or plans to take in addressing FDA's good manufacturing practice concerns

FDA Seizure Of GSK Products Exemplifies Heightened Warning Letter Gravitas

The seizure of two of GlaxoSmithKline's major prescription drugs is an example of the increased seriousness FDA is placing on individual warning letters

Schering Claritin Awaits FDA Certification; Correctol SKUs To Be Discontinued

Schering-Plough's first batch of products submitted to FDA for certification under a May 16 consent decree will include the Claritin 10 mg dose

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS127195

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