Over the course of the ongoing pandemic, the agency has seen a sharp increase in hand sanitizer products from Mexico that were labeled to contain ethanol (also known as ethyl alcohol) but tested positive for methanol contamination. Keep Reading
This action plan describes a multi-pronged approach to advance the Agency’s oversight of AI/ML-based medical software. Keep Reading
Agency takes further steps to strengthen the REMS program for transmucosal immediate-release fentanyl (TIRF) products to help ensure that the benefits of these drugs continue to outweigh the risks. Keep Reading
The U.S. Food and Drug Administration expanded the approved indication for Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza (flu) for patients 12 years of age and older after contact with an individual who has the flu. Keep Reading
The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Keep Reading
Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval. Keep Reading
In 2017, the Food and Drug Administration created a new office within the agency to oversee its lab safety program. But, 3 years later, there are still disagreements within the FDA about the office's roles and responsibilities. Keep Reading
The U.S. Food and Drug Administration announced today that Fortune Food Product, Inc., an Illinois-based processor of sprouts and soy products, has agreed to stop production until it, among other things, undertakes remedial action and complies with the Federal Food, Drug, and Cosmetic Act. Keep Reading
The agency has discovered that some hand sanitizers are being packaged in beer cans, children’s food pouches, water bottles, juice bottles and vodka bottles. Additionally, the FDA has found hand sanitizers that contain food flavors, such as chocolate or raspberry. Keep Reading
This method was used in our current investigation and may be instrumental in our efforts to better understand the dispersion of the parasite in the environment, which could help prevent future outbreaks. Keep Reading
Naloxone is a medicine that can be administered by individuals with or without medical training to help reduce opioid overdose deaths. If naloxone is administered quickly, it can counter the overdose effects, usually within minutes. Keep Reading
The FDA is revising the fact sheet for health care providers that accompanies the drug to state that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended. Keep Reading
Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Keep Reading
The outbreak of COVID-19 has called greater attention to the United States’ reliance on foreign drug manufacturers. Much of the drug manufacturing for the U.S. market happens overseas—and drugs for treating COVID-19 are no exception. Keep Reading
The FDA worked with the Centers for Disease Control and Prevention (CDC) and state partners to investigate the contamination of romaine lettuce with several strains of E. coli O157:H7 that caused three outbreaks. Keep Reading
Together, the CoE and FDA’s Office of Information Management & Technology (OIMT) will strengthen an inclusive culture of employee engagement to drive the FDA’s technology modernization efforts. Keep Reading
During COVID-19, the U.S. Food and Drug Administration will continue to utilize and implement additional alternative inspection tools and approaches while postponing domestic and foreign routine surveillance inspections. Keep Reading
U.S. Customs and Border Protection (CBP) officers seized counterfeit COVID-19 test kits during the inspection of express-consignment shipments. This is the latest in several shipments that have contained counterfeit test kits. Keep Reading
The emergency use authorization allows for remdesivir to be distributed in the U.S. and administered intravenously by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. Keep Reading
Prior experience with respiratory viruses and limited data that have emerged from China suggest that convalescent plasma has the potential to lessen the severity or shorten the length of illness caused by COVID-19. Keep Reading