FDA issues first injunction under Produce Safety Rule to Illinois-based Food Manufacturer for Repeated Food Safety Violations

FDA reports the action marks the first consent decree of permanent injunction against a firm or grower for violating public safety standards under the Produce Safety Rule enacted under the Food Safety Modernization Act of 2011.

U.S. Food and Drug Administration: National Survey Shows Encouraging Decline in Overall Youth E-Cigarette Use, Concerning Uptick in Use of Disposable Products

FDA notes the findings come as we mark today’s premarket review submission deadline, a milestone for ensuring new tobacco products, including many already on the market, undergo a robust scientific evaluation by the FDA.

FDA Provides Guidance to Industry for Detecting and Preventing Nitrosamines in Drugs: Statement from FDA Commissioner Stephen M. Hahn, M.D., and Patrizia Cavazzoni, M.D.

Nitrosamine impurities in some drug products is a serious concern, and the FDA has been working, in collaboration with regulatory counterparts around the world, to find and remove drugs with unacceptable nitrosamine impurities from the U.S. drug supply.

FDA Approves Treatment for Rare Disease Affecting Optic Nerves, Spinal Cord

NMOSD is a rare autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord. FDA reports Enspryng is the third approved treatment for the disorder.

FDA Posts Additional Postmarket Information for Essure

"The FDA continues to take concerns about Essure very seriously. Consistent with our previous updates, we are committed to continuing our postmarket evaluation of this device and providing updated information periodically.

FDA Takes Action to Limit Inorganic Arsenic Levels in Infant Rice Cereal

"The FDA is finalizing guidance today that will help protect public health by reducing infants' exposure to inorganic arsenic, which has been associated with neurodevelopmental effects.

FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action to Address Concerning Products

The FDA first warned about some of the methanol-containing hand sanitizers being sold in retail stores and online in June.

FDA In Brief: Findings from Real-World Data Study Reveal Higher Risk of Hospitalization and Death Among Cancer Patients with COVID-19, Underscore Health Disparities

"The clinical experience of people with cancer who have contracted COVID-19 is an essential resource that can help the medical community better understand the impact of the disease in this population.