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911 articles found
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FDA Authorizes Marketing of Diagnostic Aid for Autism Spectrum DisorderToday, the U.S. Food and Drug Administration authorized marketing of a device to help diagnose autism spectrum disorder (ASD). The Cognoa ASD Diagnosis Aid is a machine learning-based software intende... -
Coronavirus (COVID-19) Update: June 1, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:The FDA issued a safety communication to warn the public to st...
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Nevada-Based Bottled Water Manufacturer Agrees to Stop Production for Failure to Comply with Manufacturing RequirementsThe U.S. Food and Drug Administration announced that today Real Water Inc., a Nevada-based bottled water manufacturer, agreed to cease operations until they can comply with the Federal Food, Drug, and...
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FDA Launches Challenge to Spur Development of Affordable Traceability Tools as Part of Broader Food Safety EffortsToday, the U.S. Food and Drug Administration launched a challenge to spur the development of affordable, tech-enabled traceability tools to help protect people and animals from contaminated foods by e...
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Coronavirus (COVID-19) Update: May 28, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:This week, FDA released the Medical Countermeasures Initiative...
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FDA Seeks $6.5 Billion to Further Investments in Critical Public Health Infrastructure, Core Food Safety and Medical Product Safety ProgramsThe U.S. Food and Drug Administration is requesting a total budget of $6.5 billion as part of the President’s fiscal year (FY) 2022 budget – a nearly 8% ($477 million) increase over the agency’s FY 20...
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FDA Approves First Targeted Therapy for Lung Cancer Mutation Previously Considered Resistant to Drug TherapyToday, the U.S. Food and Drug Administration approved Lumakras (sotorasib) as the first treatment for adult patients with non-small cell lung cancer whose tumors have a specific type of genetic mutati...
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Coronavirus (COVID-19) Update: FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy sotrovimab for the treatment of mild-to-moderate COVID-19 i...
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FDA, FTC Warn Five Companies Illegally Selling Dietary Supplements Claiming to Treat InfertilityToday, the U.S. Food and Drug Administration and the Federal Trade Commission issued warning letters to five companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or...
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FDA In Brief: FDA Announces Draft Guidances to Help Increase Transparency, Assist Reporting and Timely Completion for Certain Medical Device Studies after FDA Approval or ClearanceThe following quote is attributed to William Maisel, M.D., chief medical officer and director of the Office of Product Evaluation and Quality in FDA’s Center for Devices and Radiological Health...