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Food and Drug Administration

  • Cybersecurity for medical devices

    The FDA’s recent Safety Alert regarding cybersecurity vulnerabilities in Hospira’s PCA3 and PCA5 Infusion Pump Systems has caused the in-house counsel at many medical device companies to pause and ask, “Are we ready?”

  • Ropes & Gray helps guide Bayer to patent win

    A team from Ropes & Gray that included IP litigation partner Sona De helped Bayer Healthcare Pharmaceuticals Inc. notch a win in its patent suit under the Hatch-Waxman Act against generic drug company Glenmark Pharmaceuticals.

  • The FDA's new menu labeling rules

    The Food and Drug Administration (FDA) has issued its rules requiring that calorie information be listed on menus and menu boards of chains (including franchise systems) with at least 20 units operating under the same name.

  • Prepping for battle

    So far, this IP-themed issue of InsideCounsel has taken us through the steps of monetizing and protecting IP assets. But the fact of the matter is, in this day and age, the biggest trends that in-house counsel are tracking are those involving IP litigation. Whether your company is an accused...

  • The future of preemption

    For FDA (Food and Drug Administration)-regulated companies, federal preemption can provide a potentially powerful defense to state tort claims. In recent years, the U.S. Supreme Court has decided numerous preemption cases, each emphasizing the highly context-sensitive nature of the inquiry. Determining when preemption applies and how to deploy it to...

  • Federal Circuit tries to explain ‘unclear’ biologics law

    A recent ruling by judges from the U.S. Court of Appeals for the Federal Circuit makes it more likely that Sandoz soon may be able to start selling a biosimilar that treats cancer patients.

  • Cosmeceuticals: The next wave of class-action litigation

    Dr. Albert Kligman, the dermatologist who invented the widely used acne medicine Retin-A, is credited with coining the term “cosmeceutical,” a term that consumers and the media use to refer to cosmetic products that claim to have medicinal or drug-like benefits. Cosmeceuticals are reported to be the fastest growing segment...

  • The products of tomorrow

    Rapidly changing technologies and exciting new products offer seemingly limitless opportunities for growth and progress across a broad range of industries. But the same innovative qualities that make new products likely to gain widespread publicity may also attract unwanted – and unwarranted – attention from the plaintiffs’ bar and others...

  • Veleka Peeples-Dyer appointed as partner at McDermott Will & Emery

    Peeples-Dyer will join the Washington, D.C.’s Health Industry Advisory Practice Group

  • When self-regulatory remedies can be the better alternative

    While the NAD process is technically voluntary, the FTC’s enforcement action is yet another example of why advertisers that refuse to participate in the self-regulatory process do so at their own peril.

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