U.S. Food & Drug Administration

http://www.fda.gov

More from U.S. Food & Drug Administration

FDA Holding Webinar on Animal Drug Manufacturing System eSubmitter Tool

The session will provide information about new enhancements to the system used to support the creation of electronic, secure submissions to the FDA’s Center for Veterinary Medicine for review.

FDA Issues Radiation Sterilization Update for PMA Holders

The agency is considering a master file pilot program for premarket approval (PMA) holders whose approved devices are sterilized using radiation, including gamma radiation.

FDA to Reconsider Safety of BPA in Food Packaging

The action is being taken in response to a petition from the Environmental Defense Fund and others, as well as a new study on the effects of BPA on children.

Senator Edward J. Markey Introduces Legislation to Improve Food Safety

The legislation calls for stricter regulation of Generally Recognized as Safe substances and the creation of a new FDA office to assess safety of chemicals in America’s food supply.

FDA Efforts to Result in Millions of Additional Bottles of Infant Formula

Recent steps the FDA has taken will increase the U.S. supply, leading to more infant formula on U.S. store shelves in the coming weeks and months.

FDA Flexibilities to Yield Millions of Cans of Additional Infant Formula

In the coming months, the FDA will be able to greatly increase the supply of formula, including Abbott EleCare, available to U.S. consumers through international and domestic manufacturing facilities.

FDA Releases White Paper on Quality Management Maturity

The new white paper discusses developing a framework to evaluate the QMM of pharmaceutical manufacturing sites and the benefits of a rating system.

FDA Permits Marketing for Test to Improve Diagnosis of Alzheimer’s Disease

The Lumipulse test is intended to measure the ratio of β-amyloid 1-42 and β-amyloid 1-40 concentrations found in human cerebral spinal fluid.

FDA Issues Draft Action Levels for Lead in Juice

The agency is moving to limit lead in ready-to-drink apple juice and other single-strength juices and juice blends, supporting its Closer to Zero action plan that sets forth the FDA’s science-based approach to reducing exposure to toxic elements in foods.