Posts Tagged FDA

FDA Requires Opioid Labeling Changes to Help Providers Safely Taper Dosing

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

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FDA Issues Safety Recommendations for Providers Using Surgical Staplers

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

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FDA Previews 2019 Plans to Address Opioid Epidemic

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

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FDA: Don’t Use Certain Test Strips to Monitor Blood Thinner Dosing

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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FDA Updates Providers on Lymphoma Risk Associated with Breast Implants

The Food and Drug Administration recently updated health care providers about a type of lymphoma associated with breast implants and recommendations to inform patients about the risk and report, evaluate and treat the condition. Providers, patients and manufacturers have reported 457 cases of breast implant-associated anaplastic large cell

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FDA Issues Draft Guidance on Cybersecurity for Medical Device Industry

The Food and Drug Administration today issued draft guidance that provides recommendations to the medical device industry on cybersecurity considerations for device design, labeling and documentation that the FDA recommends be included in premarket submissions for medical devices with cybersecurity risk. The guidance builds on the

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FDA Announces Actions to Strengthen Medical Device Cybersecurity

The Food and Drug Administration has released a framework to help hospitals and other health care providers plan for and respond to cybersecurity incidents involving medical devices. Developed by MITRE Corp., the “playbook” includes steps such as developing a medical device inventory and conducting training

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NASEM To Develop New Opioid Prescribing Guidelines

The Food and Drug Administration has awarded a contract to the National Academies of Sciences, Engineering, and Medicine to develop evidence-based guidelines for appropriate opioid analgesic prescribing for acute pain resulting from specific conditions or procedures. FDA Commissioner Scott Gottlieb, M.D., said the “primary scope

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FDA Issues Safety Alert on Temporary Artificial Heart

The Food and Drug Administration Aug. 17 issued a safety alert after reviewing the final results from a post-approval study conducted by SynCardia Systems for their Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System. SynCardia’s TAH-t functions as a bridge to a heart transplant

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FDA alerts providers to safety risks associated with cesium chloride

The Food and Drug Administration recently alerted health care providers to safety risks associated with cesium chloride, a mineral salt sometimes taken by cancer patients who seek alternative treatments. Reported adverse events included QT prolongation (a dangerous abnormality that can impair the heart’s ability to

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