Florham Park partner Mike Zogby was quoted in Law360’s editorial analysis, “Product Liability Regulation & Legislation: Midyear Report.”

Mike, a member of the firm’s Pharma and Life Sciences Industry Group, discussed FDA rules on off-label promotion of pharmaceutical and medical devices, including the one-year extension of a rule related to what pharmaceutical and device manufacturers can say about unapproved uses of their products. The rule would require manufacturers to add labeling for unapproved uses known to the manufacturer, and also add labeling if a manufacturer intends, based on a “totality of the evidence,” to promote a medical product for an unapproved use.

Read “Product Liability Regulation & Legislation: Midyear Report”

Source: Law360
Leave Drinker Biddle to Learn More