Category Archives: FDA

Last Week’s Important Life Science Headlines

        Litigation

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This Week’s Life Science Headlines

        Litigation

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This Week’s Life Science Headlines

        Litigation

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This Week’s Science Headlines

        Litigation

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This Week’s Life Science Headlines

        Litigation

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Claims Regarding Post-FDA Approval Problems Not Preempted

While Medical Device Amendments of 1976, 21 U.S.C. § 360k(a) provides protection to manufacturers for medical devices approved by the FDA, certain post-FDA approval activities may still give rise to claims.  In this recent case, the defendant St. Jude Medical, Inc. moved to dismiss the complaints against it for injuries allegedly resulting from St. Jude Riata leads on implantable cardiac defibrillators where the insulation failed and caused unnecessary shocks in the body.  The product was removed from the market in 2010, a warning letter was…

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This Week’s Life Science Headlines

        Litigation

Regulatory

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First Drugs Approved for Combination Treatment of Melanoma by the FDA

Melanoma is the most aggressive type of skin cancer and is the leading cause of death from skin disease.  Last week the FDA approved GSK’s Mekinist (trametinib) in combination with Tafinlar (dabrafenib) to treat patients with advanced melanoma that cannot be removed by surgery or that is metastatic. The drugs were approved under the agency’s accelerated approval program.  More information is available click here. Previously both drugs were approved by the FDA as single agents to treat late-stage or unresectable melanoma. Both drugs are…

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FDA Addresses Antibacterial Soaps and Body Washes and Opens Its Proposal to Public Comment

In December 2013, the U.S. Food and Drug Administration (“FDA”) issued a proposed rule that would require manufacturers of antibacterial hand soaps and body washes to provide substantial data to demonstrate that “their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections.” Under this proposed rule, if companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabelled to remain on the market. The…

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This Week’s Life Science Headlines

        Litigation

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