FDA

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…

FDA Takes Steps Aimed at Improving Quality, Safety and Efficacy of Sunscreens

The U.S. Food and Drug Administration today took steps aimed at improving the quality, safety, and efficacy of sunscreens as part of its implementation of…

FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations

Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single…

FDA Issues Draft Guidance on Donor Eligibility and Manufacturing of Cellular Therapies for Animals

Today, the U.S Food and Drug Administration issued for public comment two draft guidance documents that, if finalized, will help manufacturers of animal cells, tissues,…