Regulatory Intelligence on Biologics Recalls – Immunoglobulins and Vaccines are Involved in More Recalls than Other Drug Classes

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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.

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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.

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.
einforce 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.

List of Tables
Table 1: Regulatory Intelligence on Biologics Recalls, Total Number of Recalls by All Agencies, 2007–2010 
Table 2: Regulatory Intelligence on Biologics Recalls, Drug Recalls by CDER, 2007, 2008 and 2010
Table 3: Regulatory Intelligence on Biologics Recalls, Number of Drug Product Recalls by CDER by Class, 2007, 2008 and 2010
Table 4: Regulatory Intelligence on Biologics Recalls, Drug Recalls by CBER, 2007, 2008 and 2010
Table 5: Regulatory Intelligence on Biologics Recalls, Number of Biological Product Recalls by CBER by Class, 2007, 2008 and 2010
Table 6: Regulatory Intelligence on Biologics Recalls, Product Recalls by CDER, CBER and Other Agencies, 2007, 2008 and 2010
Table 7: Regulatory Intelligence on Biologics Recalls, Total Number of Biologics Recalls, 2004
Table 8: Regulatory Intelligence on Biologics Recalls, Total Number of Biologics Recalls, 2005
Table 9: Regulatory Intelligence on Biologics Recalls, Total Number of Biologics Recalls, 2006
Table 10: Regulatory Intelligence on Biologics Recalls, Total Number of Biologics Recalls, 2007
Table 11: Regulatory Intelligence on Biologics Recalls, Total Number of Biologics Recalls, 2008
Table 12: Regulatory Intelligence on Biologics Recalls, Total Number of Biologics Recalls, 2009
Table 13: Regulatory Intelligence on Biologics Recalls, Total Number of Biologics Recalls, 2010
Table 14: Regulatory Intelligence on Biologics Recalls, , Biologics Recalls by Reason for Recall, 2004–2010
Table 15: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Reason for Recall, By Year, 2004–2010
Table 16: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Therapy Area, 2004–2010
Table 17: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Therapy Area, By Year, 2004–2010
Table 18: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Drug Class, 2004–2010
Table 19: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Drug Class, By Year, 2004–2010
Table 20: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Dosage Form, 2004–2010
Table 21: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Dosage Form, By Year, 2004–2010
Table 22: Regulatory Intelligence on Biologics Recalls, Recalls by Companies, 2004–2010
Table 23: Regulatory Intelligence on Biologics Recalls, Recalls by Companies, By Year, 2004–2010
Table 24: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Reason for Recall, 2007–2010 
Table 25: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Therapy Area, 2007–2010
Table 26: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Drug Class, 2007–2010
Table 27: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Dosage Form, 2007–2010
Table 28: Regulatory Intelligence on Biologics Recalls, Recalls by Companies, 2007–2010
Table 29: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Reason for Recall, 2007
Table 30: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Therapy Area, 2007
Table 31: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Drug Class, 2007
Table 32: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Dosage Form, 2007
Table 33: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Companies, 2007
Table 34: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Reason for Recall, 2008
Table 35: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Therapy Area, 2008
Table 36: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Drug Class, 2008
Table 37: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Dosage Form, 2008
Table 38: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Companies, 2008
Table 39: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Reason for Recall, 2009
Table 40: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Companies, 2009
Table 41: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Reason for Recall, 2010
Table 42: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Therapy Area, 2010
Table 43: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Drug Class, 2010
Table 44: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Dosage Form, 2010
Table 45: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Companies, 2010
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