Highlights and a hidden hazard - the FDA's new labeling regulations

Article Abstract:

The US Food and Drug Administration (FDA) is working to make the official descriptions of prescription drugs, known as package inserts or labeling, more helpful and user-friendly. However, along with these very modest alterations of drug labeling to be phased in over seven years beginning June 30, 2006, the changes include a provision that could severely limit the accountability of companies that fail to adequately evaluate or report the risks associated with their products.

Pharmaceutical industry, Labeling, United States. Food and Drug Administration

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Who should protect the public? The Supreme Court and medical device regulation

Article Abstract:

The Supreme Court's expected decision by June 2008, related to Charles Riegel versus Medtronic case is reviewed. The resolution could have great implication on government protection of consumers from the risks associated with medical devices and prescription drugs.

Government domestic functions, Regulation, Licensing, and Inspection of Miscellaneous Commercial Sectors, Medical Instruments and Supplies, Medical Instruments & Equipment, Medical Equipment and Supplies Manufacturing, Medical Instruments & Supplies, Consumer Protection Laws, Company legal issue, Consumer protection, Investigations, Medical equipment, Medical equipment and supplies industry, Medical equipment industry, United States. Supreme Court, Medical test kit industry, Health policy, Physiological apparatus, Medtronic Bio-Medicus Inc.

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