This week, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) to JUUL Labs Inc. for all of their products currently marketed in the United States. As a result, the company must stop selling and distributing these products. In addition, those currently on the U.S. market must be removed, or riskContinue Reading

The U.S. Food and Drug Administration took two actions this week to expand the use of the antiviral drug Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease. This provides another treatment option to reduce the risk of hospitalization in high-risk patients. Previously,Continue Reading

The U.S. Food and Drug Administration today announced that, on behalf of the agency, the U.S. Marshals Service conducted a mass seizure of FDA-regulated spices and food additive products held for sale under unsanitary conditions. Specifically, these food products were exposed to widespread rodent infestation as well as other pests,Continue Reading

After the Department of Veterans Affairs sent an email to all employees mandating that all its health care personnel receive the COVID-19 shots, the Department of Justice (DOJ) issued an absurd Memorandum Opinion (memo) that completely ignores the law. NOTE: FDA EMERGENCY USE AUTHORIZATION FDA must ensure that recipients of the vaccineContinue Reading

Yesterday, the Food and Drug Administration revoked emergency authorization for the malaria drug promoted by President Trump, hydroxychloroquine, warning of serious side effects and increasing evidence that the treatment doesn’t work. The FDA also warned doctors against prescribing the drugs in combination with remdesivir, a drug currently shown to helpContinue Reading