• Regulatory NewsRegulatory News

    CDRH Warns Idaho Wheelchair Manufacturer for Unapproved Modifications

    The videos at 21 st Century Scientific’s website wheelchairs.com show people taking their wheelchairs off-road, in the sand and at high speeds. But the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) told the Idaho-based company in a warning letter posted Tuesday that these modifications to their wheelchairs were never approved by the agency. “Use on these terrains and functions that enable the device to lift the user, tilt the...
  • Lawsuit Against Genzyme Seeks Damages for Fabrazyme Shortages

    • 12 March 2012
    A lawsuit filed by an Idaho woman claims negligence on the part of Genzyme, now a subsidiary of Sanofi, led to persistent drug shortages and consequently the death of her husband. Shortages of Fabrazyme, used to treat Fabry Disease, started in 2009 when viral contamination was discovered at a Genzyme manufacturing facility. Shortages were further exacerbated when additional contamination was found by the US Food and Drug Administration later in 2009, leading to a situati...