FDA Coronavirus (COVID-19) Update: November 14th, 2020
November 14, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
The FDA has issued a new Consumer Update urging consumers to avoid fraudulent flu products and offering tips on how to spot them.
Coronavirus
FDA Coronavirus (COVID-19) Update: November 8th, 2020
November 8, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has authorized the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection, which are antibodies that bind to a specific part of a pathogen and have been observed in a laboratory setting to decrease SARS-CoV-2 viral infection of cells.
Coronavirus
FDA Coronavirus (COVID-19) Update: October 25th, 2020
October 25, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
On Thursday, the FDA approved Veklury (remdesivir), the first drug approved to treat COVID-19 Coronavirus, for use in adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 Coronavirus requiring hospitalization.
Coronavirus
FDA Approves First Treatment for COVID-19 Coronavirus
October 24, 2020
Silver Spring, MD – The U.S. Food and Drug Administration has approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 Coronavirus requiring hospitalization.
Coronavirus
FDA Coronavirus (COVID-19) Update: September 26th, 2020
September 26, 2020
Silver Spring, MD – The U.S. Food and Drug Administration has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
Coronavirus
FDA Takes Actions to Help Lower U.S. Prescription Drug Prices
September 25, 2020
Silver Spring, MD – On Thursday, September 24th, 2020, the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration took actions to help provide safe, effective, and more affordable drugs to American patients as part of the Safe Importation Action Plan, fulfilling the aspect of the July Executive Order on drug pricing to complete the rulemaking to allow states to import certain prescription drugs from Canada.
Analytics reports confirm Tennessee is changing how health care is delivered across the state.
FDA Coronavirus (COVID-19) Update: August 28th, 2020
August 29, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) continues to take action in the ongoing response to the COVID-19 Coronavirus pandemic:
The FDA is warning consumers about alcohol-based hand sanitizers that are being packaged in containers that may appear as food or drinks and may put consumers at risk of serious injury or death if ingested.
Coronavirus
FDA Coronavirus (COVID-19) Update: August 26th, 2020
August 26, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 Coronavirus pandemic:
The FDA issued a new Consumer Update entitled, Is Your Hand Sanitizer on FDA’s List of Products You Should Not Use?
Coronavirus
FDA Updates Analysis of Medical Device Reports of Breast Implant Illness, Breast Implant-Associated Lymphoma
August 24, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) is providing an update on adverse events reported to the Agency related to breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and systemic signs and symptoms referred to by patients as breast implant illness (BII), which some patients report after receiving breast implants.
FDA also announces Qualification of a Medical Device Development Tool to Aid in the Effectiveness Assessment of Devices Used in Breast Reconstruction. (FDA)
FDA Coronavirus (COVID-19) Update: August 22nd, 2020
August 22, 2020
Silver Spring, MD – The U.S. Food and Drug Administration has announced that it has taken the following actions in its ongoing response effort to the COVID-19 Coronavirus pandemic:
Coronavirus
