U.S. Food & Drug Administration

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More from U.S. Food & Drug Administration

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Cybersecurity in Medical Devices: FDA Announces New Draft Guidance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.

FDA Launches Challenge to Spur Development of Affordable Traceability Tools

The challenge is part of the agency’s broader food safety efforts to help protect people and animals from contaminated foods by enabling the rapid identification of their sources and helping remove them from the marketplace.

FDA & CDC: No Transmission of COVID-19 Through Food or Food Packaging

FDA and CDC continue to underscore that there is no credible evidence of food or food packaging associated with or as a likely source of viral transmission of COVID-19.