Tag: FDA

FDA limits authorization for J&J COVID-19 vaccine

In a new message to providers May 5, 2022, CMS is noting that the FDA has limited the authorized use of the Janssen (Johnson & Johnson) COVID-19 vaccine. The vaccine is now only authorized for patients 18 years or older: For whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate Who […]

At-home COVID-19 testing on the horizon

At-home COVID-19 testing may be made available in order to allow for a greater number of people to be tested in less time. Doing so would also minimize the risk of infected people traveling to a testing location. LabCorp was the first company to receive FDA authorization for home collection of COVID-19 test samples back […]

FDA provides panel to evaluate diagnostic tests available for COVID-19

The U.S. Food and Drug Administration (FDA) is providing a SARS-COV-2 reference panel for the evaluation of diagnostic tests for COVID-19. The panels safeguard the quality of the tests and validation of new assay. They also test the calibration and monitoring of assay performance. The FDA panel is available to commercial and laboratory developers who […]

First diagnostic test with home collection option for COVID-19 authorized by FDA

The first diagnostic test with a home collection option for COVID-19 has been authorized by the U.S. Food and Drug Administration (FDA). The FDA reissued the emergency use authorization (EUA), allowing the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCT Test to enable testing of samples self-collected by patients at home, according to an FDA news […]

FDA bans healthcare antiseptics containing Triclosan

In a final rule published this week, the U.S. Food and Drug Administration (FDA) determined that over-the-counter (OTC) antiseptics used in healthcare settings containing the ingredient Triclosan–the most commonly used active ingredient in OTC antiseptics–are not generally recognized as safe and effective for use in healthcare settings. The rule clarifies that the term “healthcare antiseptic” […]

Increase in off-label use of antipsychotics among dementia residents: A national issue

Antipsychotic medications (APM) approved by the Food and Drug Administration (FDA) to treat schizophrenia and/or bipolar disorder are increasingly used to treat behavioral symptoms of dementia in nursing homes, according to a systematic review published by BMC Geriatrics and corroborated by a report published in 2015 by the Government Accountability Office (GAO). The effectiveness of […]

FDA issues new draft guidelines affecting SNFs

On January 7, the Federal Drug Administration (FDA) issued draft guidelines which would make changes to blood glucose monitoring test systems (BGMS) in both hospitals and long-term care facilities. This draft guidance document describes studies and criteria the FDA recommends for BGMSs which are for prescription point-of-care use. When finalized, the FDA intends for this […]

FDA warns of potential infection risks tied to mattresses

In an April notice, the Food and Drug Administration (FDA) is alerting health care providers, health care facility staff, and caregivers that damaged or worn covers for medical bed mattresses can allow blood and body fluids to penetrate medical bed mattresses, posing a risk of infection to patients. The FDA is providing recommendations for reducing […]