A federal court in Texas has ordered Pharm D Solutions to stop producing or distributing compounded drugs intended to be sterile until the company complies with federal law and other requirements, the Food and Drug Administration announced. In addition, a federal court in Illinois
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The Food and Drug Administration has alerted providers and patients that batteries in certain Medtronic implantable pacemakers and cardiac resynchronization therapy pacemakers may drain more quickly than expected without warning. The devices provide pacing for slow heart rhythms and heart failure. FDA said it has
Read more →The Food and Drug Administration recently approved the first generic naloxone nasal spray, an emergency treatment for opioid overdose intended for use in the community. Generic injectable naloxone products have been available for use in health care settings for years. The FDA has previously approved
Read more →The Food and Drug Administration recently proposed reclassifying surgical staplers for internal use as moderate-risk rather than low-risk medical devices. The change would allow the agency to require premarket review of the devices and establish special controls such as mandatory performance testing of the device’s
Read more →The Food and Drug Administration recently alerted hospitals and others to a temporary shortage of a tracheostomy tube used to help adult and pediatric patients breathe in healthcare facilities and at home. Made by Smiths Medical, the Bivona tracheostomy tubes are sterilized with ethylene oxide
Read more →The Food and Drug Administration has ordered manufacturers to immediately stop selling and distributing surgical mesh products for transvaginal repair of pelvic organ prolapse in the U.S. Women planning to have the procedure should discuss other treatment options with their doctors, and women who have
Read more →The Food and Drug Administration recently announced changes to the prescribing information included in outpatient opioid pain medication labels to provide expanded guidance to health care professionals on how to safely decrease or discontinue these medications in patients who are physically dependent on them. The
Read more →The Food and Drug Administration recently issued recommendations for healthcare providers to reduce the risk of adverse events associated with surgical staplers and staples for internal use. Among other recommendations, FDA recommends providers carefully follow the stapler manufacturer’s instructions for use, have a range
Read more →Food and Drug Administration Commissioner Scott Gottlieb, M.D., recently announced the agency’s 2019 agenda to address the opioid epidemic. Among other actions, the agency is considering using its authority under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of
Read more →The Food and Drug Administration recently warned physicians and patients who use medical devices to monitor levels of the blood thinner warfarin that certain test strips used with the devices may provide inaccurate results and should not be relied on to adjust the drug dosage.
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