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FDA: Do Not Use Cue Health's Covid-19 Tests Due to Risk of False Results

Hacker News

The FDA issues alert about risk of false results with Cue Health’s COVID-19 Tests due to modifications made without FDA authorization that have a strong likelihood to impact performance.

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5 Things You Didn’t Know About FDA Data-Driven Software Validation

Smart Data Collective

Data analytics has been very important for the FDA. Software validation by the Food and Drug Administration (FDA) is a vital step in the oversight process towards ensuring the systems your organization uses when manufacturing and distributing regulated products are of the highest quality. How do you validate FDA-regulated software?

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Philips allegedly hid 3700 complaints about sleep apnea machines from U.S.

Hacker News

Philips failed to report at least 3,700 complaints about its sleep apnea devices and respirators to the United States regulator FDA since 2010, NRC, research collective ProPublica, and the Pittsburgh Post Gazette reported based on their analysis of over 100,000 public reports.

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I am dying of squamous cell carcinoma, and potential treatments are out of reach

Hacker News

Alex Tabarrok writes about how "when the FDA fails to approve a good drug, people die but the bodies are buried in an invisible graveyard." " I'd like to make that graveyard a little bit more visible because I'm going to be buried in it, in a few weeks or months. A squamous cell carcinoma tumor…

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FDA FSMA: Providing value beyond compliance

IBM Journey to AI blog

The FDA’s Food Modernization Safety Act (FSMA) has sparked a significant amount of discussion, and rightly so. The change, challenge and benefits are here FDA FSMA will have significant global implications for traceability. To achieve that outcome, the FDA FSMA comes with a bundle of new policies, procedures and penalties.

Analytics 110
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iFoodDS and IBM forge new path to food safety with IBM Food Trust™

IBM Journey to AI blog

In a world where food safety is paramount, compliance with the FDA Food Tracebility Rule FSMA 204 is non-negotiable. The FDA’s Food Safety Modernization Act (FSMA) Rule 204 is a game-changer for food traceability. The FDA estimates that the rule will help reduce outbreak investigations to less than one week.

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Redefining clinical trials: Adopting AI for speed, volume and diversity

IBM Journey to AI blog

Our analysis of the voluntarily reported Form FDA 1572 BMIS database reveals a potential lack of sustainability in the investigator pool, both in the United States (US) and globally (Exhibit 2). For instance, the FDA released guidance in November 2020 titled, “Enhancing the diversity of clinical trial populations.”

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