Ranbaxy’s $500 Million GMP Settlement Would Be Second Most Expensive For Rx Manufacturing Violations
This article was originally published in PharmAsia News
Executive Summary
Ranbaxy Laboratories said it has signed a consent decree with FDA and set aside $500 million to settle a related Department of Justice investigation involving GMP violations and data integrity issues at its Indian facilities.
You may also be interested in...
GSK’s $750 Mil. DoJ Settlement: When GMP Violations Equal Healthcare Fraud
GlaxoSmithKline’s $750 million settlement with the Department of Justice raises a worrisome question for industry: will violations of current good manufacturing practices become a target for whistleblower suits?
Schering NDAs Are Clear For Review Under FDA Consent Decree
Schering-Plough NDAs will not be subject to extra scrutiny under the GMP consent decree with FDA
Amgen’s Lumakras: FDA Flags ‘Marginal’ Efficacy Results, Potential Systemic Bias In Lung Cancer Trial
Company seeks conversion from accelerated to regular approval for the first KRAS G12C inhibitor on the market, but the agency is asking its Oncologic Drugs Advisory Committee whether the progression-free survival primary endpoint in the CodeBreaK 200 confirmatory trial can be reliably interpreted.