Istituzioni

Today, the FDA issued an emergency use authorization for the drug baricitinib, in combination with remdesivir, for the treatment of COVID-19 in hospitalized adults and pediatric patients 2+ years requiring supplemental oxygen, invasive mechanical ventilation, or ECMO.

FDA releases new tool to communicate foodborne illness outbreak information frequently and as soon as the FDA begins an outbreak investigation.

The FDA issued an emergency use authorization for the first COVID-19 diagnostic test that allows for self-collection and testing at home and provides test results in 30 minutes or less.

Coronavirus (COVID-19) Update

FDA is committed to transparency around the EUA process

Coronavirus (COVID-19) Update

FDA approves first intratumoral injection to treat dogs with non-metastatic, skin-based (cutaneous) mast cell tumors (MCTs). The FDA is also approving Stelfonta to treat non-metastatic MCTs located under the dog’s skin (subcutaneous), in particular areas of a dog’s leg.

Coronavirus (COVID-19) Update

Coronavirus (COVID-19) Update

Coronavirus (COVID-19) Update

FDA has issued a draft guidance encouraging food manufacturers to voluntarily declare sesame in the ingredient list on food labels. While most products declare sesame as an ingredient, there are times when sesame is not required to be declared, such as in flavors and spices.

Coronavirus (COVID-19) Update

Today, the FDA issued an emergency use authorization for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients.

The FDA has issued final guidance which provides the agency’s current thinking on steps to broaden eligibility criteria in clinical trials through inclusive trial practices. The guidance provides recommendations for how to increase enrollment of underrepresented populations in clinical trials.

FDA has permitted marketing of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD).

Today, the U.S. Food and Drug Administration authorized the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection.

FDA is releasing a final guidance to help compounders identify and prevent insanitary conditions at facilities. The guidance provides recent examples of insanitary conditions and details corrective actions that facilities should take when they identify these conditions.

Coronavirus (COVID-19) Update

Coronavirus (COVID-19) Update

Leadership from the U.S. Food and Drug Administration, the U.S. Customs and Border Protection (CBP), and the U.S. Immigration and Customs Enforcement, Homeland Security Investigations (ICE-HSI) signed a Memorandum of Understanding (MOU) to stop harmful products that pose a threat to public health an