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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

FDA Law Blog

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 These AI requests often address complicated scientific scenarios in which a submitter has already provided some information, but FDA is not completely satisfied. Average Number of Industry Days to MDUFA IV Decision 54.69

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Rewiring the body clock: Deep brain imaging reveals unexpected complexity in jet lag adjustment

Medical Xpress

In a study published in Nature Communications , led by researchers at National Taiwan University (NTU) and National Tsing Hua University (NTHU), scientists used the deepest-ever two-photon calcium imaging in awake mice to directly observe how individual SCN neurons respond to light. But what we observed was much more complicated."

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Texas invests $50M in psychedelic drug research to treat addiction

Medical Xpress

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