Table of Contents
1 Table Of Contents
1.2 List of Tables
2 Regulatory Intelligence on Biologics Recalls: Executive Summary
2.1 Immunoglobulins and Vaccines are More Prone to Recalls than Other Drug Classes
2.2 The Most Biologics Recalls were in 2010
2.3 Quality Defects were the Most Frequent Reason for Biologics Recalls
3 Regulatory Intelligence on Biologics Recalls: Introduction
3.1 Drugs and Biologics Inspections and Warning Letters
3.2 Public Health Service Act and Biologics
3.3 Drug Recall Process
3.4 Drug Recalls Reported by CDER
3.5 Drug Recalls Reported by CBER
3.6 GBI Research Report Guidance
4 Regulatory Intelligence on Biologics Recalls: Overview
4.1 Overview of Biologics
4.2 Overview of Biologics Manufacturing Process
4.3 Biologics Recalls
4.4 Reasons for Recalls
4.5 Risk Management for Drugs and Biologics
4.5.1 Labeling Revisions on ESAs Following FDA Recommendation and CMS Changes to Reimbursement
4.5.2 Updated Labeling of Tysabri to Warn Against Increased Risk of Progressive Multifocal Leukoencephalopathy (PML)
4.6 Regulatory Responsibilities and Procedures Involving Recalls
4.6.1 Reasons for Manufacturers to Initiate Recalls
4.6.2 FDA Responsibilities and Procedures Outline
4.6.3 Responsibilities of the Agencies Involved
4.7 Case Study 1: Octagam 5% Returned to Market after Resolution of Manufacturing Issues by Octapharma
4.7.1 Octagam 5% Recalled from Markets Due to Increase of Thromboembolic Events (TEEs)
4.7.2 Changes to the Manufacturing Process
4.7.3 Favorable Opinion of Regulatory Authorities and Approval of the Product
4.8 Case Study 2: Heparin Crisis a Reflection of FDA Failure
4.8.1 Heparin Contamination Forced Several Companies to Recall Products
4.8.2 Source of Contamination was in China
4.8.3 Regulatory Failure Led to Contaminated Heparin Distribution
4.9 Case Study 3: Shortened Expiration Period for 2009 H1N1 Vaccine in Pre-filled Syringes by Sanofi Pasteur
4.9.1 Five Lots with Lower than Pre-Specified Potency Levels Recalled from the Market
4.9.2 Change of Expiration Date for the Remaining Lots as a Protective Measure
5 Regulatory Intelligence on Biologics Recalls – Trends Analysis
5.1 Analysis of Biologics Recalls 2004–2010
5.1.1 Reasons for Biologics Recalls
5.1.2 Biologics Recalls by Therapy Area
5.1.3 Biologics Recalls by Drug Class
5.1.4 Biologics Recalls by Different Dosage Forms
5.1.5 Biologics Recalls by Companies
5.2 Analysis of Biologics Recalls 2007–2010
5.2.1 Reasons for Biologics Recalls
5.2.2 Biologics Recalls by Therapy Area
5.2.3 Biologics Recalls by Drug Class
5.2.4 Biologics Recalls by Dosage Form
5.2.5 Biologics Recalls by Companies
5.3 Analysis of Biologics Recalls – 2007
5.3.1 Reasons for Biologics Recalls, 2007
5.3.2 Biologics Recalls by Therapy Area, 2007
5.3.3 Biologics Recalls by Drug Class, 2007
5.3.4 Biologics Recalls by Dosage Form, 2007
5.3.5 Biologics Recalls by Companies, 2007
5.4 Analysis of Biologics Recalls – 2008
5.4.1 Reasons for Biologics Recalls, 2008
5.4.2 Biologics Recalls by Therapy Area, 2008
5.4.3 Biologics Recalls by Drug Class, 2008
5.4.4 Biologics Recalls by Dosage Form, 2008
5.4.5 Biologics Recalls by Companies, 2008
5.5 Analysis of Biologics Recalls – 2009
5.5.1 Reasons for Biologics Recalls, 2009
5.5.2 Biologics Recalls by Therapy Area, 2009
5.5.3 Biologics Recalls by Drug Class, 2009
5.5.4 Biologics Recalls by Dosage Form, 2009
5.5.5 Biologics Recalls by Companies, 2009
5.6 Analysis of Biologics Recalls – 2010
5.6.1 Reasons for Biologics Recalls, 2010
5.6.2 Biologics Recalls by Therapy Area, 2010
5.6.3 Biologics Recalls by Drug Class, 2010
5.6.4 Biologics Recalls by Dosage Form, 2010
5.6.5 Biologics Recalls by Companies, 2010
6 Regulatory Intelligence on Drug Recalls: Appendix
6.1 Market Definitions
6.2 Abbreviations
6.3 Research Methodology
6.3.1 Coverage
6.3.2 Regulatory Intelligence on Biologics Recalls – Overview
6.3.3 Regulatory Intelligence on Biologics Recalls – Trend Analysis
6.4 Contact Us
6.5 Disclaimer
6.6 Sources