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  • Regulatory NewsRegulatory News

    FDA Warns Against Using Implanted Pumps With Unapproved Drugs

    The US Food and Drug Administration (FDA) on Wednesday warned physicians against using implantable pumps to deliver pain medications directly into patients’ spinal fluid with drugs they were not approved for use with.   Using drugs that have not been approved for compatibility with the pumps could lead to dosing errors, pump failure, opioid withdrawal, infection, fever, vomiting, muscle spasms, cognitive changes and cardiac or respiratory distress, FDA says.   “The...
  • Regulatory NewsRegulatory News

    FDA Issues Untitled Letter for Website Promotion of an Opioid 10 Days Before PDUFA Date

    The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) is calling on Durect and Pain Therapeutics to pull promotional materials on their websites for their unapproved Remoxy (oxycodone) extended-release capsules as the sites incorrectly suggest that the investigational new drug is safe and effective. The letter, dated 9 September for Cupertino, CA-based Durect and Austin-based Pain Therapeutics, comes a little more than two weeks b...
  • Regulatory NewsRegulatory News

    FDA Questions First PMA for Synthetic Cartilage Implant Ahead of Advisory Panel

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Monday raised key questions about the effectiveness of Cartiva’s first-of-its-kind synthetic cartilage implant, which is intended to treat osteoarthritis pain in the first joint of the big toe. The implant, which is made of an organic polymer-based biomaterial comprised of polyvinyl alcohol and saline, is designed to work in a manner similar to how biologic cartilage works, ...
  • OTC Topical Pain Relievers Can Cause Dangerous Reactions, Say Regulators

    Regulators with the US Food and Drug Administration (FDA) have sent out a warning to consumers indicating that over-the-counter topical pain relievers such as BENGAY and Icy Hot have in some cases led to dangerous skin reactions. After receiving numerous reports of consumers suffering mild to severe chemical burns from products containing menthol, methyl salicylate or capsaicin, FDA said it had combed its adverse event reporting databases and found 43 cases in which a ...
  • Senators Launch Investigation Into 'Dubious Marketing Practices' of Pain Pill Manufacturers

    • 10 May 2012
    Explosive allegations have emerged from two prominent Senators regarding marketing tactics used by a number of pharmaceutical companies, including Purdue Pharma, Endo Pharmaceuticals and Johnson & Johnson, which are alleged to have engaged in "misinformation and dubious marketing practices." The Senators, Max Baucus (D-MT) and Charles Grassley (R-IA), charge the companies were involved in establishing "improper relationships between [the companies] and the organizati...
  • FDA Panel Recommends Restarting Testing of Controversial Pain Drugs

    An US Food and Drug Administration (FDA) Advisory Committee Panel recommended clinical trials testing anti-nerve growth factor inhibitors (anti-NGF inhibitors) be allowed to continue, with certain precautions, reports The Associated Press. The Arthritis Advisory Committee (AAC) voted 21-0 on 12 March to recommend that research continue in light of the unmet needs of patients. Panelists noted many patients do not respond to existing pain medications such as aspirin a...
  • US Regulators Reassessing Anti-NGF Pain Pills Linked to Joint Damage

    The US Food and Drug Administration (FDA) is reassessing whether or not manufacturers of anti-nerve growth factor (anti-NGF) pain pills should be allowed to proceed with clinical trials after a two year hold on existing clinical trials, reports Reuters . The trials were stopped in 2010 after hundreds of clinical trials participants required joint replacement surgery after taking the drugs, though testing was allowed to continue for terminally ill cancer patients. Pfize...