U.S. Food & Drug Administration

http://www.fda.gov

More from U.S. Food & Drug Administration

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.

FDA Issues New Guidance to Increase Racial and Ethnic Diversity in Clinical Trials

The agency’s focus on inclusion in trials for all medical products aligns with Biden Administration’s Cancer Moonshot goal of addressing inequities and beyond.

Cybersecurity in Medical Devices: FDA Announces New Draft Guidance

The new guidance deals with quality system considerations and the content of premarket submissions for members of the medical device industry, as well as Food and Drug Administration staff.

FDA Recommends Use of Duodenoscopes With Innovative Designs to Enhance Safety

The agency is providing new information supporting the transition to fully disposable duodenoscopes and those with disposable components, as well as new information on completed post-market surveillance studies.

FDA Issues Guidance on Enforcement Discretion Policies for Certain FSMA Regulations

FDA Issues Plan to Help Modernize Foodborne Illness Outbreak Responses

The plan will help the agency evolve its outbreak investigations to meet today’s needs using the most modern-day tools available and set a clear pathway to achieving its response goals.