News

Coronavirus (COVID-19) Update: June 4, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: On June 1, the…

FDA Approves New Drug Treatment for Chronic Weight Management, First Since 2014

Today, the U.S. Food and Drug Administration approved Wegovy (semaglutide) injection (2.4 mg once weekly) for chronic weight management in adults with obesity or overweight…

FDA Alerts Health Care Providers to Stop New Implants of Certain Ventricular Assist Device System

The U.S. Food and Drug Administration is alerting health care providers to no longer implant end-stage heart failure patients with Medtronic’s Heartware Ventricular Assist Device…

FDA In Brief: FDA provides new guidance to further enhance the security of prescription drugs in the U.S. supply chain

The following quote is attributed to Donald D. Ashley, J.D., Director of the Office of Compliance for FDA's Center for Drug Evaluation and Research “Ensuring…

FDA Authorizes Marketing of Diagnostic Aid for Autism Spectrum Disorder

Today, the U.S. Food and Drug Administration authorized marketing of a device to help diagnose autism spectrum disorder (ASD). The Cognoa ASD Diagnosis Aid is…

Coronavirus (COVID-19) Update: June 1, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: The FDA issued a…

Nevada-Based Bottled Water Manufacturer Agrees to Stop Production for Failure to Comply with Manufacturing Requirements

The U.S. Food and Drug Administration announced that today Real Water Inc., a Nevada-based bottled water manufacturer, agreed to cease operations until they can comply…

FDA Launches Challenge to Spur Development of Affordable Traceability Tools as Part of Broader Food Safety Efforts

Today, the U.S. Food and Drug Administration launched a challenge to spur the development of affordable, tech-enabled traceability tools to help protect people and animals…

Coronavirus (COVID-19) Update: May 28, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: This week, FDA released…

FDA Seeks $6.5 Billion to Further Investments in Critical Public Health Infrastructure, Core Food Safety and Medical Product Safety Programs

The U.S. Food and Drug Administration is requesting a total budget of $6.5 billion as part of the President’s fiscal year (FY) 2022 budget –…