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The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: On Tuesday October 5, the FDA…
The following quote is attributed to Binita Ashar, M.D., director of the Office of Surgical and Infection Control Devices in FDA’s Center for Devices and…
The following quote is attributed to Mitch Zeller, J.D., director of FDA’s Center for Tobacco Products: “The FDA is responsible for ensuring that new tobacco…
Today, the U.S. Food and Drug Administration announced several actions related to surgical stapler and staple regulation and safety. “At the heart of our public…
The U.S. Food and Drug Administration today announced that California, Florida, Utah and Wisconsin have entered into domestic mutual reliance agreements with the agency. These…
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…
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…
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…
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…
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…
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FDA Acts to Protect Children from Unapproved Fluoride Drug Products