Category Archives: Regulatory

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Regulatory

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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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This Week’s Life Science Headlines

        Litigation

Regulatory Recalls

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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 Life Science Headlines

        Litigation

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This Week’s Life Science Headlines

        Litigation

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Direct Mailers for Aranesp Targeted by FDA

The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) recently criticized the makers of Aranesp for a direct mailer that was allegedly in violation of the Federal Food, Drug and Cosmetic Act (FD&C Act). Specifically, the mailer was found to be false or misleading because it omitted important risk information, suggested use beyond that which was substantiated, made unsubstantiated efficacy claims, and omitted material facts. OPDP also found that the mailer evidenced that Aranesp was intended for a new…

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