News

FDA Revises Hospital and Health System Compounding Guidance to Help Preserve Patient Access to Compounded Drugs

Compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug. The FDA is continuing our efforts…

Coronavirus (COVID-19) Update: October 5, 2021

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

Coronavirus (COVID-19) Update: FDA Authorizes Additional OTC Home Test to Increase Access to Rapid Testing for Consumers

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the ACON Laboratories Flowflex COVID-19 Home Test, an over-the-counter (OTC) COVID-19…

FDA Finalizes Two Foundational Rules for Companies Seeking to Market New Tobacco Products

Today, the U.S. Food and Drug Administration issued two final rules for the premarket review of new tobacco products. These foundational rules provide additional information…

Federal officials seize spices and food additive products held under insanitary conditions from a Florida warehouse

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…

Coronavirus (COVID-19) Update: October 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: On Sep. 24, Janet…

FDA to Hold Advisory Committee Meetings to Discuss Emergency Use Authorization for Booster Doses and COVID-19 Vaccines for Younger Children

Today, the U.S. Food and Drug Administration is announcing two upcoming meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss newly…

Youth E-cigarette Use Remains Serious Public Health Concern Amid COVID-19 Pandemic

A study released today from the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention (CDC) estimated that more than…

FDA Clears First Major Imaging Device Advancement for Computed Tomography in Nearly a Decade

Today, the U.S. Food and Drug Administration cleared the first new major technological improvement for Computed Tomography (CT) imaging in nearly a decade. “Computed tomography…

FDA In Brief: FDA Warns Consumers of Risk of Exposure to Unsafe Levels of Radiation with Safe-T-Lite UV WAND

The following quote is attributed to Thalia Mills, Ph.D., director, Division of Radiological Health, Office of In Vitro Diagnostics and Radiological Health, FDA’s Center for…