New CDC effort will track impact of COVID-19 and other public health threats on long-term care facilities … FDA pushes to cut sodium by 12% in American foods in bid to confront chronic disease epidemic...
Clinical briefs for Thursday, June 10
By
Alicia Lasek
Jun 10, 2021
Operator changes plans, will wait for full FDA approval to enforce COVID vaccination deadline among staff … Colorado drops mask mandate for assisted living communities … FDA panel member resigns over...
U.S. lawmakers ramp up scrutiny of FDA following agency’s approval of controversial Alzheimer’s drug
By
Alicia Lasek
Sep 07, 2021
The FDA is being asked to help explain how Aduhelm (aducanumab) met accelerated approval criteria when so many experts — including internal advisers — have flagged insufficient safety and efficacy...
BD investigating reports of false positives from COVID-19 tests
By
Danielle Brown
Sep 16, 2020
New Jersey-based medical technology company Becton Dickinson, or BD, is conducting an investigation following reports that its COVID-19 point-of-care testing equipment is producing false positive results...
FDA approves fast-results antigen test for COVID-19
By
Alicia Lasek
May 11, 2020
The first federally approved test of its kind, the point-of-care diagnostic is administered using a nasal swab.
Boosters on the way: LTC residents, healthcare workers may top fed’s list after CDC approves 3rd shot
By
Alicia Lasek
Aug 16, 2021
The Biden administration has secured 100 million COVID-19 vaccine doses as part of a strategy to provide additional shots to already vaccinated priority groups this fall, investigators have been told....
CDC briefing: Top officials talk up vaccine plans, focus on long-term care
By
Alicia Lasek
Oct 22, 2020
Federal health officials touted transparency and nationwide distribution plans while keeping their eye on Phase 1 vaccine recipients, including LTC residents and workers.
HHS extends coverage for COVID-19 screening at nursing homes
By
Danielle Brown
Sep 01, 2020
Nursing homes in states that prohibit the use of point-of-care COVID-19 tests to screen for the disease can now do so after the Department of Health and Human Services extended coverage to include congregate...
FDA halts use of REGEN-COV, Eli Lilly monoclonal antibodies
By
Alicia Lasek
Jan 26, 2022
The Food and Drug Administration has revoked its emergency use authorizations for two monoclonal antibody cocktails that have served as COVID-19 treatment mainstays in long-term care facilities.
FDA advisers recommend Moderna COVID booster for seniors, others at high risk
By
Alicia Lasek
Oct 15, 2021
In a unanimous vote, advisers agreed that vulnerable Moderna vaccine recipients should be offered a third shot. A half dose will be effective and will help protect against side effects, the drugmaker says.