The Food and Drug Administration (FDA) recently decided to require so-called “black box warnings” on nearly 400 products, warning of the risks of combining certain opioid medications and central nervous system depressants called benzodiazepines. Opioids are a class of powerful, pain-reducing medications that include oxycodone, fentanyl, and morphine. Certain prescription cough suppressants also contain opioids. … Continue Reading
The FDA has long sought to ban manufacturers from promoting off-label uses of approved drugs and medical devices. In taking the position that manufacturers and their agents cannot promote off-label uses, the FDA suggests they are safeguarding the public from misbranded medical products and ensuring that manufacturers do not circumvent the drug- and device-approval processes. … Continue Reading
FDA recently released a draft guidance entitled "Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices)," which discusses the risks of transmitting various forms of transmissible spongiform encephalopathies, including Mad Cow Disease (found in cattle), scrapie (found in sheep), chronic waste disease (found in deer), and Creutzfeldt-Jakob Disease (found in humans). The guidance is applicable to all medical devices that contain or are exposed to animal-derived materials, with the exception of in vitro diagnostic devices.… Continue Reading
