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
The CDC 2019 novel coronavirus test is intended for use with upper and lower respiratory specimens collected from people who meet CDC criteria for 2019-nCoV testing. Keep Reading