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Government Report Outlines FDA Recall Management Weaknesses
07-05-2011
Mike Rozembajgier
A new government report finds that the Food and Drug Administration (FDA) has often failed to properly manage the recall process for contaminated foods imported to the United States. The report draws attention to the often complex and critically important logistics involved as regulators, importers and businesses work together to manage a recall. More
Pharmaceutical Industry Launches Shared Digital Oversight Platform
07-01-2011
Mike Rozembajgier
A private pharmaceutical industry information company recently introduced a new database network for reporting and collecting information on adverse events resulting from prescription drug use. The database, RxEvent.org, was launched last week by PDR Network, a leading distributor of drug labeling information and the publisher of the Physicians’ Desk Reference. RxEvent is likely to have a significant impact on the Food and Drug Administration’s (FDA) oversight of the industry and the recall management process for pharmaceutical products. More
FDA Issues Report on Global Supply Chain Oversight
06-27-2011
Mike Rozembajgier
Among the most significant outcomes of increased globalization is the international networking of supply chains and commercial trade. Global markets are increasingly interconnected and reliant on one other for the production and manufacture of a wide variety of goods, including food products, electronics, and children’s toys. In theory this can help reduce the cost of manufacturing a product, but it can also complicate the recall process. More
New GAO Report May Impact Automotive Safety and Recall Process
06-24-2011
Mike Rozembajgier
A new Government Accountability Office (GAO) report examining how the National Highway Transportation Administration (NHTSA) could improve the safety defect recall process for automobiles may have a major impact on auto manufacturers in coming months and years. The NHTSA study – which was conducted in the wake of a record number of vehicle recalls in 2010 – makes a number of recommendations, many of which revolve around improving recall communication and boosting NHTSA’s recall authority. More
New Regulations Fast Approaching After Crib Recall Management
06-22-2011
Mike Rozembajgier
Over the past four years, over 11 million cribs have been recalled. Manufacturers in the U.S. and abroad have seen their recall management teams put to the test. Now manufacturers, as well as retailers, child care centers and other businesses that offer cribs as a service to consumers, are getting ready to meet new crib safety requirements. More
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