FDA – Page 18 – medicarereport.org

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Emerging Health Issues FDA

FDA warns of false results from Thermo Fisher’s COVID-19 test

(By Maia Anderson for Becker’s Hospital Review ) The FDA warned healthcare providers and labs Aug. 17 of issues with

Eileen Cook August 18, 2020

The FDA accepted Biogen’s Alzheimer’s drug submission. Next up, a highly anticipated outside expert review

(By Adam Feuerstein for ST A T) The Food and Drug Administration has agreed to review a marketing application submitted

Eileen Cook August 7, 2020

Emerging Health Issues FDA

FDA puts hand sanitizers on import alert, adds more to do-not-use list

(By Maia Anderson for Becker’s Hospital Review ) The FDA has placed certain brands of hand sanitizer on an import

Eileen Cook July 29, 2020

Alzheimer’s/Dementia FDA Part D/Prescription Drugs

Could aducanumab be the first drug to slow Alzheimer’s disease?

The biotechnology company Biogen along with Japanese pharmaceutical company applied for a Biologics License Application with the U.S. Food and

Eileen Cook July 22, 2020

Emerging Health Issues FDA

FDA publishes list of 55 hand sanitizers that may be toxic, says some users have died

(By Maia Anderson for Becker’s Hospital Review ) The FDA has published a list of 55 hand sanitizers that may

Eileen Cook July 10, 2020

FDA Part D/Prescription Drugs

FDA urged to increase safety warnings on common diabetes drug

(By Maia Anderson for Becker’s Hospital Review ) Public Citizen, a consumer advocacy group, filed a citizen’s petition June 24

Eileen Cook June 24, 2020

FDA Medical Technology Telehealth

FDA clears Apple Watch ECG for remote patient visits during pandemic: 6 things to know

(By Laura Dyrda for Becker’s Hospital Review ) The FDA expanded the use of noninvasive patient-monitoring technologies, including the electrocardiogram

Eileen Cook June 16, 2020

FDA Medical Technology Part D/Prescription Drugs

6 recent drug, device recalls

(By Maia Anderson for Becker’s Hospital Review ) Medical device and drug recalls, whether voluntary or mandated by the FDA,

Eileen Cook June 15, 2020

Emerging Health Issues FDA Medical Technology

FDA approves Fitbit emergency ventilator

(By Jackie Drees for Becker’s Hospital Review ) The FDA granted Fitbit emergency use authorization for its new emergency ventilator,

Eileen Cook June 5, 2020

FDA Part D/Prescription Drugs

FDA asks 5 drugmakers to recall metformin products

( By Maia Anderson for Becker’s Hospital Review ) The FDA has asked five drugmakers to voluntarily recall their metformin

Eileen Cook June 2, 2020