COVID-19: CDC, FDA and CMS Guidance
This page includes AHA Today stories and other AHA content on coronavirus COVID-19 guidance from the CDC, FDA, and CMS.
Johnson & Johnson was notified that the Food and Drug Administration now will require that the company add to the label of its COVID-19 vaccine a warning of a small, increased risk of Guillain-Barré syndrome, a rare but potentially serious neurological condition.
Responding last month to an AHA letter, the Centers for Medicare & Medicaid Services said it will continue to remain flexible in its approach to surveys if a hospital experiences a COVID-19 surge.
The Food and Drug Administration July 2 authorized for emergency use one more batch of drug substance for the Janssen (Johnson & Johnson) COVID-19 vaccine at an Emergent BioSolutions facility in Baltimore.
The Food and Drug Administration revoked its emergency use authorizations for all disposable respirators lacking National Institute of Occupational Safety and Health approval, and for decontamination and bioburden reduction systems used to extend the use of disposable respirators.
Letter to OSHA requesting a six-month delay of its compliance dates for the recently announced COVID-19 Health Care Emergency Temporary Standard, thus giving hospitals and health systems ample time to implement the policy’s many new requirements.
The Food and Drug Administration June 25 formally updated its patient and provider fact sheets for the Moderna and Pfizer COVID-19 vaccines to include warnings about the increased risk of heart inflammation in patients.
The Food and Drug Administration authorized for emergency use a new drug to treat hospitalized patients receiving systemic corticosteroids who require supplemental oxygen, mechanical ventilation or extracorporeal membrane oxygenation.
The Centers for Disease Control and Prevention awarded states and other jurisdictions $200 million in supplemental funding from the American Rescue Plan Act to hire and train disease intervention specialists to prevent and respond to COVID-19 and other infectious diseases.
The Centers for Disease Control and Prevention updated requirements for health care providers participating in the COVID-19 Vaccination Program to clarify that participants may not sell or divert COVID-19 vaccine or ancillary materials purchased for the program; reproduce the program’s COVID-19…
The Food and Drug Administration authorized for emergency use one more batch of drug substance manufactured for the Janssen (Johnson & Johnson) COVID-19 vaccine at an Emergent BioSolutions facility in Baltimore.