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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 if additional testing is required or justification would suffice), responsible individuals, proposed timelines, and any clarifying questions for FDA. Average Number of Industry Days to MDUFA IV Decision 54.69

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

Medical Xpress

The goal is to support clinical trials and bring in another $50 million in private investment to help ibogaine win approval from the U.S. Other states like Oregon and Colorado have already launched legal clinics using psilocybin, the compound found in mushrooms, The Times reported. Food and Drug Administration (FDA).

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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. Your feedback is important to us.

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Preemies receive sucrose for pain relief—new research shows it doesn't stop long-term impacts on development

Medical Xpress

Long-term effects of pain in early life We collected data on the number of procedures, clinical exposures and sucrose doses from three NICUs across Canada. However, we do not guarantee individual replies due to the high volume of messages. One of these sites does not use sucrose for acute pain management.

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Do You Hear What I Hear? One Year of OTC Hearing Aids

FDA Law Blog

The rule established a new category of OTC hearing aids for individuals with mild to moderate hearing loss, allowing them to purchase hearing aids directly from stores or online retailers without the need for a medical examination, prescription, or fitting adjustment by an audiologist. However, FDA missed that deadline.