In-Demand Biologics Recalls Study by GBI Research Most Recently Published at MarketPublishers.com

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In-demand market study “Regulatory Intelligence on Biologics Recalls – Immunoglobulins and Vaccines are Involved in More Recalls than Other Drug Classes” developed by GBI Research has been recently published by Market Publishers Ltd. The report informs that during 2004–2010, biologics recalls have increased to a great extent, of which the recalls for vaccines and immunoglobulins were more frequent than for other drug classes.

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During 2004–2010, biologics recalls have increased to a great extent, of which the recalls for vaccines and immunoglobulins were more frequent than for other drug classes. The underlying causes of recalls varied from serious adverse events, labeling errors and quality defects, to defects that occurred during the manufacturing process. Over the review period, the highest number of biologics recalls occurred in 2010, especially in the infectious diseases and immunodeficiency disorders therapy areas.

In-demand market study “Regulatory Intelligence on Biologics Recalls – Immunoglobulins and Vaccines are Involved in More Recalls than Other Drug Classes” developed by GBI Research has been recently published by Market Publishers Ltd.

Report Details:

Title: Regulatory Intelligence on Biologics Recalls – Immunoglobulins and Vaccines are Involved in More Recalls than Other Drug Classes
Published: March, 2012
Pages: 72
Price: US$ 3,500.00
http://marketpublishers.com/report/medicine_pharmaceuticals_biotechnology/drugs_biotechnology/regulatory_intelligence_on_biologics_recalls_v_immunoglobulins_n_vaccines_are_involved_in_more_recalls_than_other_drug_classes.html
The study provides comprehensive up-to-date coverage of biologics recalls issued or reported with the US Food and Drug Administration (FDA) and its constituent agencies.

Report Scope:

  •     data and numerical figures on the number of biologics recalls issued according to the year of recall and recalling firm, from 2007–2010;
  •     analysis of leading therapeutic areas and dosage forms for major biologics recalls;
  •     analysis of reasons for recall, along with in-depth analysis of underlying reasons and patterns from 2007–2010;
  •     case studies of companies that have recalled biologic products and re-released products with manufacturing changes or labeling changes.

Report Contents:

1 TABLE OF CONTENTS

1.1 List of Tables
1.2 List of Figures

2 INTRODUCTION

2.1 Drugs and Biologics Inspections and Warning Letters
2.2 Public Health Service Act and Biologics
2.3 Drug Recall Process
2.4 Drug Recalls Reported by CDER
2.5 Drug Recalls Reported by CBER
2.6 GBI Research Report Guidance

3 REGULATORY INTELLIGENCE ON BIOLOGICS RECALLS: OVERVIEW

3.1 Overview of Biologics
3.2 Overview of Biologics Manufacturing Process
3.3 Biologics Recalls
3.4 Reasons for Recalls
3.5 Risk Management for Drugs and Biologics
3.5.1 Labeling Revisions on ESAs Following FDA Recommendation and CMS Changes to Reimbursement
3.5.2 Updated Labeling of Tysabri to Warn Against Increased Risk of Progressive Multifocal Leukoencephalopathy (PML)
3.6 Regulatory Responsibilities and Procedures Involving Recalls
3.6.1 Reasons for Manufacturers to Initiate Recalls
3.6.2 FDA Responsibilities and Procedures Outline
3.6.3 Responsibilities of the Agencies Involved
3.7 Case Study 1 - Octagam 5% Returned to Market after Resolution of Manufacturing Issues by Octapharma
3.7.1 Octagam 5% Recalled from Markets Due to Increase of Thromboembolic Events (TEEs)
3.7.2 Changes to the Manufacturing Process
3.7.3 Favorable Opinion of Regulatory Authorities and Approval of the Product
3.8 Case Study 2 - Heparin Crisis a Reflection of FDA Failure
3.8.1 Heparin Contamination Forced Several Companies to Recall Products
3.8.2 Source of Contamination was in China
3.8.3 Regulatory Failure Led to Contaminated Heparin Distribution
3.9 Case Study 3 - Shortened Expiration Period for 2009 H1N1 Vaccine in Pre-filled Syringes by Sanofi Pasteur
3.9.1 Five Lots with Lower than Pre-Specified Potency Levels Recalled from the Market
3.9.2 Change of Expiration Date for the Remaining Lots as a Protective Measure

4 REGULATORY INTELLIGENCE ON BIOLOGICS RECALLS – TRENDS ANALYSIS

4.1 Analysis of Biologics Recalls 2004–2010
4.1.1 Reasons for Biologics Recalls
4.1.2 Biologics Recalls by Therapy Area
4.1.3 Biologics Recalls by Drug Class
4.1.4 Biologics Recalls by Different Dosage Forms
4.1.5 Biologics Recalls by Companies
4.2 Analysis of Biologics Recalls 2007–2010
4.2.1 Reasons for Biologics Recalls
4.2.2 Biologics Recalls by Therapy Area
4.2.3 Biologics Recalls by Drug Class
4.2.4 Biologics Recalls by Dosage Form
4.2.5 Biologics Recalls by Companies
4.3 Analysis of Biologics Recalls – 2007
4.3.1 Reasons for Biologics Recalls, 2007
4.3.2 Biologics Recalls by Therapy Area, 2007
4.3.3 Biologics Recalls by Drug Class, 2007
4.3.4 Biologics Recalls by Dosage Form, 2007
4.3.5 Biologics Recalls by Companies, 2007
4.4 Analysis of Biologics Recalls – 2008
4.4.1 Reasons for Biologics Recalls, 2008
4.4.2 Biologics Recalls by Therapy Area, 2008
4.4.3 Biologics Recalls by Drug Class, 2008
4.4.4 Biologics Recalls by Dosage Form, 2008
4.4.5 Biologics Recalls by Companies, 2008
4.5 Analysis of Biologics Recalls – 2009
4.5.1 Reasons for Biologics Recalls, 2009
4.5.2 Biologics Recalls by Therapy Area, 2009
4.5.3 Biologics Recalls by Drug Class, 2009
4.5.4 Biologics Recalls by Dosage Form, 2009
4.5.5 Biologics Recalls by Companies, 2009
4.6 Analysis of Biologics Recalls – 2010
4.6.1 Reasons for Biologics Recalls, 2010
4.6.2 Biologics Recalls by Therapy Area, 2010
4.6.3 Biologics Recalls by Drug Class, 2010
4.6.4 Biologics Recalls by Dosage Form, 2010
4.6.5 Biologics Recalls by Companies, 2010

5 REGULATORY INTELLIGENCE ON DRUG RECALLS - APPENDIX

5.1 Market Definitions
5.2 Abbreviations
5.3 Research Methodology
5.3.1 Coverage
5.3.2 Regulatory Intelligence on Biologics Recalls – Overview
5.3.3 Regulatory Intelligence on Biologics Recalls – Trend Analysis
5.4 Contact Us
5.5 Disclaimer
5.6 Sources

LIST OF TABLES

LIST OF FIGURES

More new studies by the publisher can be found at GBI Research page.

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Tanya Rezler
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