The U.S. Food and Drug Administration (FDA) recently held a Patient Engagement Advisory Committee meeting focused on clinical trial informed consent practices. Below, we summarize key takeaways from the meeting, including a...more
Last week, the U.S. Food and Drug Administration (FDA) proposed two new rules for classification of certain, previously unclassified wound dressings and liquid wound washes containing antimicrobials, which would categorize...more
AdvaMed recently hosted its annual MedTech Conference in Anaheim, California, at which Hogan Lovells lawyers and regulatory specialists convened with business leaders, scientists, investors, regulators, and others across the...more
While devices that stimulate the brain invasively have generally been available since 2002, and devices that do so non-invasively have been available since 2013, in recent years, the U.S. Food and Drug Administration (FDA)...more