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
Health related products are presented daily for import, it is U.S. Customs and Border Protection’s mission to ensure only those that meet federal safety requirements enter the American commerce. Keep Reading
Frank Richard Ludlow, 59, of West Sussex, United Kingdom, was charged with one count of introducing misbranded drugs into interstate commerce, a felony offense that carries a statutory maximum sentence of three years in federal prison. Keep Reading
The shipments, which arrived aboard air cargo flights from Germany and Poland, were destined to addresses in states across the United States, but Florida was the most popular. Keep Reading
The agency intends to temporarily suspend enforcement of portions of the federal veterinarian-client-patient relationship (VCPR) requirements relevant to certain FDA regulations. Keep Reading
The nation’s blood supply requires a steady supply of donors who generously donate millions of units of potentially life-saving blood and blood components each year. Every two seconds, a patient needs a blood transfusion. Keep Reading
The agency does not intend to take action against manufacturing firms that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs during this ongoing public health emergency. Keep Reading
After careful consideration, the FDA is postponing most foreign inspections through April, effective immediately. Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis. Keep Reading
The FDA is particularly concerned that products that claim to cure, treat or prevent serious diseases like COVID-19 may cause consumers to delay or stop appropriate medical treatment, leading to serious and life-threatening harm. Keep Reading
These cybersecurity vulnerabilities may allow an unauthorized user to wirelessly crash the device, stop it from working, or access device functions normally only available to the authorized user. Keep Reading
A manufacturer has alerted the FDA to a shortage of a human drug that was recently added to the drug shortages list. The manufacturer just notified FDA that this shortage is related to a site affected by coronavirus. Keep Reading
To date, this test has been limited to use at CDC laboratories; the authorization allows the use of the test at any CDC-qualified lab across the country. Keep Reading