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Drug Recalls and Warning Letters - Increasing Numbers Caused by Manufacturing Errors and Regulatory Non-compliance Issues
GBI Research, Nov 2011, Pages: 128
GBI Research’s report, “Drug Recalls and Warning Letters - Increasing Numbers Caused by Manufacturing Errors and Regulatory Non-compliance Issues”, provides in-depth analysis of Warning Letters, drug recalls issued or reported with the US Food and Drug Administration (FDA) and its constituent agencies. The report analyzes warning letters from the issuing agencies and reason for these warning letters. The report contains year by year detailed analysis about warning letters issued for various reasons by regulatory authorities. The report is built on data and information sourced from the FDA database of warning letters and drug recalls and in-house analysis by GBI Research’s team of industry experts.
GBI Research indicates that the warning letters and drug recalls have significantly increased during 2007-2010, due to various underlying causes which are explained in detail in the report. The report also provides analysis of warning letters individually issued by the Center for Drug Evaluation (CDER), the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Food Safety and Applied Nutrition (CFSAN), and the Center for Veterinary Medicine (CVM). The increase in the number of warning letters can be attributed to manufacturing defects present in recalled products. In the report, detailed analysis of recalled products, with the year of recall, recalling firm, dosage form, therapy area, reason for recall and the subset reason for recalls, is provided.
The report presents the year by year drug recall analysis by the recalling firms along with the reason for recall. In the analysis Class I drug recalls have been specially covered, while analysis for other types of recall have also been made. The report analyzes the percentage distribution of drug recalls in terms of dosage form, therapy area and other areas.
Scope
- The data and numerical figures on the number of warning letters and drug recalls issued according to the year of recall, recalling firm, and reporting FDA agency for 2007-2010.
- Analysis of leading therapeutic areas and dosage forms for major drug recalls were issued
- Analysis of reasons for recall, along with in-depth analysis of underlying reasons and showing its pattern from 2007-2010.
- In this report the warning letters and drug recalls were analyzed by drug class of the recalled drug products.
Reasons to buy
- Understand the pattern of warning letters and drug recalls, along with their underlying causes, so as to enable you to undertake various strategies in order to protect products from encountering safety issues.
- To analyze the major reasons for recall, along with the therapy areas and class of recalled drugs most vulnerable, so as to strengthen the areas which may lead to quality defects in your company’s products.
- Reinforce quality and manufacturing strategies so as to be complaint with the current regulatory norms.
- Develop key strategic initiatives by understanding the key focus areas of the warning letters and drug recalls.
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