GBI Research’s report, “Regulatory Intelligence on Biologics Recalls – Immunoglobulins and Vaccines are Involved in More Recalls than Other Drug Classes”, provides in-depth analysis of biologics recalls issued or reported with the US Food and Drug Administration (FDA) and its constituent agencies. The report analyzes biologics recalls on the basis of the reason for recall, therapy area, drug class, dosage forms and the recalling company, on a year-to-year basis from 2007–2010. The report is built on data and information sourced from the FDA database of biologics recalls and in-house analysis by GBI Research’s team of industry experts.
GBI Research found that biologics recalls have significantly increased from 2004–2010 due to a number of underlying causes, which are explained in detail in the report. Of biologics recalls made between these years, recalls for vaccines and immunoglobulins were higher than other drug classes. The reasons for recalls varied from serious adverse events, labeling errors and quality defects, to manufacturing defects. Of the biologics recalled since 2004, the highest number of recalls occurred in 2010, followed by 2008. In 2010, the infectious diseases and immunodeficiency disorders therapy areas had the most biologics recalls.
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.
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Reasons to buy
Understand the pattern of biologics recalls, along with their underlying causes, in order to enable you to undertake strategies to protect products from encountering safety issues.
Analyze the key reasons for recalls, along with the therapy areas and class of recalled biologics most vulnerable, so as to strengthen the areas which may lead to quality defects in your company’s products.
Reinforce quality and manufacturing strategies in order to be complaint with the current regulatory norms.
Develop strategic initiatives through understanding of the key focus areas of biologics recalls.
Table of Contents
1 Table of Contents
1 Table of Contents 3
1.1 List of Tables 5
1.2 List of Figures 6
2 Introduction 8
2.1 Drugs and Biologics Inspections and Warning Letters 8
2.2 Public Health Service Act and Biologics 9
2.3 Drug Recall Process 9
2.4 Drug Recalls Reported by CDER 11
2.5 Drug Recalls Reported by CBER 13
2.6 GBI Research Report Guidance 16
3 Regulatory Intelligence on Biologics Recalls: Overview 17
3.1 Overview of Biologics 17
3.2 Overview of Biologics Manufacturing Process 18
3.3 Biologics Recalls 19
3.4 Reasons for Recalls 19
3.5 Risk Management for Drugs and Biologics 20
3.5.1 Labeling Revisions on ESAs Following FDA Recommendation and CMS Changes to Reimbursement 20
3.5.2 Updated Labeling of Tysabri to Warn Against Increased Risk of Progressive Multifocal Leukoencephalopathy (PML) 21
3.6 Regulatory Responsibilities and Procedures Involving Recalls 21