Despite the fact that the Food and Drug Administration approved its third continuous glucose monitoring device and incorporated a mobile app in March, Medicare beneficiaries still can’t take full...
Expect false positives: FDA letter to providers explains COVID antigen test results
By
Alicia Lasek
Nov 05, 2020
The agency clarifies that rapid antigen tests, “like all diagnostic tests,” are subject to false positive results, especially in low prevalence settings. It offers recommendations for administering...
LTC continues prep for complex COVID booster shots after unanimous panel vote
By
Danielle Brown
Sep 20, 2021
Nursing homes and long-term care pharmacies eager to give booster shots to residents and workers moved a step closer in the administrative process after the federal government secured a key regulatory...
Feds wait for lowered vaccine efficacy to recommend COVID-19 booster shots
By
Alicia Lasek
Jul 22, 2021
COVID-19 vaccine booster shots will not be necessary until mRNA vaccines become less effective, federal health officials say. But immunocompromised Americans are potential near-term recipients, they told...
FDA panel endorses emergency use authorization for Pfizer COVID-19 vaccine
By
Danielle Brown
Dec 10, 2020
Nursing home residents and workers may be just days away from getting the initial doses of the first COVID-19 vaccine, after a federal advisory panel approved its emergency use Thursday.
FDA takes closer look at antibacterial products
Dec 18, 2013
It may be time to put away the antibacterial hand soap and body wash at home and the office. The Food and Drug Administration said Monday manufacturers of antibacterial products will have to prove the...
Feds revoke emergency use of some respirators, mask decontamination in healthcare settings
By
Alicia Lasek
Jul 02, 2021
Healthcare personnel are no longer authorized to use certain respirators not approved by NIOSH or technology for cleaning disposable masks, the FDA says.
FDA warns: Emergency alert pendants carry potential for choking, death risks
Sep 24, 2009
A popular emergency alert pendant could pose a deathly choking hazard, the Food and Drug Administration cautioned consumers Tuesday.
Study questions fish oil claims, popularity
By
Kristen Fischer
Aug 24, 2023
One in every five adults aged more than 60 years takes fish oil supplements, despite many warnings that they have no benefit for heart health. A new study sheds light on what the product labels say that...
FDA: Evusheld may be less effective against latest COVID variants
By
Alicia Lasek
Oct 05, 2022
Evusheld, a preventive COVID-19 antibody for high-risk patients, may lose efficacy in the face of newly emerging variants, the FDA has informed clinicians.