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  • Regulatory NewsRegulatory News

    FDA Issues New Guidance on Osteoporosis Drug Development

    The US Food and Drug Administration (FDA) on Monday issued new draft guidance calling for drugmakers to conduct long-term nonclinical bone quality studies for osteoporosis treatments. According to FDA, such studies are necessary for osteoporosis drugs to determine whether the drugs result in poorer bone quality when taken for long periods of time. Additionally, FDA says these studies should be nonclinical, as "there are no validated and reliable methods for the noninvasi...
  • Four Former Executives Barred from Federal Programs for Unauthorized Human Testing

    Four executives once associated with bone product and medical device manufacturer Synthes will be barred from participating in any federal healthcare program after serving prison time for what prosecutors said was a disregard for patient safety, federal health officials have announced. The four-Michael Huggins, formerly COO; John Walsh, director of regulatory affairs; Thomas Higgins, president of Synthes' spine division; and Richard Bohner, VP of operations-were sente...
  • Draft Recommendation by NICE Offers Split Decision on Bone Healing Device

    The UK's National Institute for Health and Clinical Excellence (NICE) has opened a consultation on its  draft medical technology guidance  on the use of a device to heal fractured bones. The draft guidance recommends use by the National Health System (NHS) of Smith & Nephew's EXOGEN ultrasound bone healing system in treating long bone fractures that have failed to heal after 9 months. Long bone fractures are suitable for treatment if the fracture is stab...
  • EMA Issues Warning on Osteoporosis Medicines

    The European Medicines Agency (EMA) announced Friday, 20 June it would recommend against the long-term use of calcitonin-containing medicines, most commonly used to treat or prevent osteoporosis While the drugs will still be permitted for short-term use for some indications, the agency said there was evidence of an increased risk of cancer when the medications are taken over the long-term. As a result, the medicines should no longer be used to treat osteoporosis, EMA sai...