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

FDA Law Blog

After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.

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Podcast: AI, innovation, and value-based care in medicine

Permanente Medicine

Contributing to this challenge is the exponential growth of information, an expanding population of older adults, and office visit documentation. Information is coming at clinicians, whether they be doctors, nurses, pharmacists, faster than ever, and there is a transparency that exists around us.

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FDA Releases Final Guidance on Use of Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

FDA Law Blog

is used in a clinical investigation of a drug or biologic under IND and the DHT meets the definition of a significant risk device a submission of an IDE to the FDA is required unless all the information required for the IDE is contained in the IND. smartphones and tablets) for remote data acquisition in a clinical investigation.

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OTAT Becomes the Office of Therapeutic Products (OTP) and Kicks off Town Hall Series – They appear to be tired of writing the same “Complete Response” Letters

FDA Law Blog

When on the bleeding edge of new product development, it can be hard to know ahead of time what the agency is looking for in terms of CMC information. The standard practice is for FDA to engage with companies on an individual basis through formal meetings and deliver directed feedback to specific sponsor questions.

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Hearing Loss in Geriatrics and Palliative Care: A Podcast with Nick Reed and Meg Wallhagen

GeriPal

We talk with Nick and Meg about: Why hearing loss is important not just in geriatrics but also for those caring for seriously ill individuals. Communication techniques we can use when talking to individuals with hearing loss. And honestly in undergrad I was like, “Engineering is really hard. How to screen for hearing loss.

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

Medical Xpress

More information: ScienceDirect has more on ibogaine. Journal information: Nature Medicine © 2025 HealthDay. The content is provided for information purposes only. However, we do not guarantee individual replies due to the high volume of messages. All rights reserved. Your feedback is important to us.

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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. The content is provided for information purposes only.

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