Coronavirus (COVID-19) Update: Daily Roundup

Coronavirus (COVID-19) Update: Daily Roundup of FDA Actions, October 19, 2020

The FDA re-issues Emergency Use Authorization for certain filtering facepiece respirators.

The FDA reissued the Emergency Use Authorization (EUA) for certain filtering face-piece respirators (FFRs) that are manufactured in China and are not approved by the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH).

Today, FDA issued a Drug Safety Communication announcing label changes that limit the use of pain-relieving and fever-reducing nonsteroidal anti-inflammatory drugs (NSAIDs) after around 20 weeks gestation or later in pregnancy.

Today, the FDA approved Inmazeb, a mixture of three monoclonal antibodies, as the first FDA-approved treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients.

The FDA issues and implements new guidance regarding molecular influenza and RSV tests.

FDA has posted five warning letters issued to companies marketing dietary supplements containing cesium chloride. FDA will continue to take action against dietary supplements that contain cesium chloride because of significant safety concerns.

The FDA and the Federal Trade Commission issue warning letters for selling fraudulent COVID-19-related products.

The FDA updates dashboard on the Coronavirus Treatment Acceleration Program (CTAP) webpage.

FDA announced awards for six new clinical trial research grants totaling over $16 million over the next four years. The grants, awarded through the Congressionally-funded Orphan Products Grants Program, enhance the development of medical products for patients with rare diseases.

FDA’s mission to protect and promote public health has always relied on a rigorous analysis of the scientific data available and we’re dedicated to ensuring our staff’s safety by continuing to strengthen a culture that prioritizes workplace safety.

The FDA issues letter to healthcare providers regarding SARS-CoV-2 testing, and a warning letter for failure to comply with regulatory reporting requirements.

FDA issued a warning letter to Battelle Memorial Institute for failure to comply with regulatory requirements for medical device reporting.

The FDA launches new COVID-19 vaccine webpage and issues guidance with recommendations for vaccine sponsors.

Coronavirus (COVID-19) Update: Daily Roundup for October 5, 2020

Today, the FDA and its regulatory counterparts in Mexico enhanced a partnership to broaden and strengthen the scope of their existing partnership to include the safety of all human food regulated by the FDA.

Coronavirus (COVID-19) Update: Daily Roundup

Today, the FDA approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of adults with malignant pleural mesothelioma that cannot be removed by surgery.

Coronavirus (COVID-19) Update: Daily Roundup