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...
Another state considers terminally ill access to experimental drugs
By
John Hall
Mar 10, 2015
Despite opposition from some drug makers and provider groups, Illinois lawmakers are considering several bills that would allow terminal patients to try unapproved experimental drugs to extend their lives.
FDA hands down guidance on mobile apps
By
Elizabeth Newman
Dec 01, 2013
The Food and Drug Administration has issued final guidance on mobile medical apps.
FDA — full of poop?
By
Jacqueline Vance, RNC, CDONA/LTC
Jun 11, 2013
Every few days I read the Food and Drug Administration (FDA) news to see if there is anything relevant to eldercare that I should be aware of. Recently, I came across an extremely eye-opening item.
FDA advisers to vote on first drug to treat Alzheimer’s
By
Alicia Lasek
Oct 28, 2020
Advisers will consider whether to recommend that the amyloid beta-removing drug aducanumab be approved. The FDA has not reviewed an application for a new Alzheimer’s treatment for at least 15 years.
Painkiller distribution could be curtailed
By
James M. Berklan
Mar 02, 2013
An advisory panel has recommended making it more difficult for long-term care residents and others to receive certain painkillers. Providers criticize the proposal, saying it could leave seniors suffering...
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....