FDA Law Blog

FEBRUARY 7, 2023

Part 814), and for conducting clinical trials (21 C.F.R. Or, to put it another way: We have not yet met an engineer who enjoys remediating the documents for development work that was done in the past. Second, if clinical data will be needed to support the marketing application, compliance with design controls is required.

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FDA Law Blog

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

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Imperial Center Family Medicine

MAY 5, 2025

It’s similar to revving a car engine for too long while staying still. People with clinical depression often have elevated cortisol levels, potentially leading to high blood pressure over time. However, chronic stress keeps your body in a continuous state of high alert. Finding healthy emotional outlets is essential.

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Permanente Medicine

MAY 20, 2025

” Related AI scribes story: Analysis: AI scribes save physicians time, improve patient interactions and work satisfaction Dr. Nguyen also highlighted the potential to utilize artificial intelligence and Kaiser Permanente’s extensive medical database to develop predictive analytic models aimed at enhancing patient care.

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33 Charts

FEBRUARY 24, 2022

It comes from Automattic engineer Mike Shelton in 2018. Industrialized healthcare positions patients as units in clinical workflows. If you like The People Margin you might like our Clinical Industrialization Archives. I love this concept of the people margin. Shelton wasn’t talking about medicine but he could have been.

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GeriPal

MAY 5, 2022

Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? Lastly, I also just want to give a shout out to the last article above which also includes this lovely checklist of methods to address hearing loss in clinical encounters. I’m guessing not. Transcript.

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FDA Law Blog

FEBRUARY 22, 2023

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. The generation of HF data is a detailed and fairly burdensome process, although certainly short of a full-blown clinical study.

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FDA Law Blog

DECEMBER 15, 2024

For tissue-engineered medical products, examples may include biomechanical testing to assess the ability of a vascular graft to tolerate repeat access without leaking, permeability testing to assess the characteristics of a skin graft, or cellular distribution throughout a cell scaffold construct.

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FDA Law Blog

OCTOBER 10, 2023

Non-Clinical Recommendations The draft guidance highlights non-clinical review areas that are generally relevant across 510(k) Implants and offers recommendations for performance data to include in a 510(k) submission. We find that this information is noteworthy for manufacturers to consider.

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FDA Law Blog

JULY 10, 2023

By Philip Won & Adrienne R. Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. But that is only the beginning. After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. The stakes are high.

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FDA Law Blog

OCTOBER 6, 2022

The Agency recommends determining the process requirements early in the development process because late changes in the development program will introduce uncertainty later that may result in a clinical hold. In addition, they should know how to control for analytical method variability prior to starting the clinical trial.

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FDA Law Blog

JANUARY 2, 2022

In Silico Clinical Trials, where “device performance is evaluated using a ‘virtual cohort’ of simulated patients with realistic anatomical and physiological variability representing the indicated patient population.”. As FDA indicates, it is especially important to consider these issues within the clinical context (conditions of use).

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Physician's Practice

JUNE 27, 2025

This may cause you to question the airline’s attention to details like engine maintenance or losing passenger’s luggage. This article inspired by Shep Hyken’s article appearing in Forbes Magazine Neil Baum, MD , a Professor of Clinical Urology at Tulane University in New Orleans, LA.

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FDA Law Blog

JANUARY 2, 2022

In Silico Clinical Trials, where “device performance is evaluated using a ‘virtual cohort’ of simulated patients with realistic anatomical and physiological variability representing the indicated patient population.”. As FDA indicates, it is especially important to consider these issues within the clinical context (conditions of use).

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The Medical Futurist

JUNE 21, 2025

4) Cureskin The artificial intelligence-based app was developed by two engineers previously working for Google , and it aims to compensate for the lack of dermatologists in India. (*There are widely varying figures, ranging from 66% to 90% depending on the source of information.) Cureskin aims to help alleviate the situation.

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The Clinical Problem Solvers

JULY 14, 2021

Uché Blackstock shared an example of how she experienced a tension between a scarcity mindset and an abundance mindset when deciding whether to continue part-time clinical work or to devote full-time effort to the organization she founded. National Academies of Sciences, Engineering, and Medicine 2021. Blackstock, U. 2020, January 08).

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Medical Xpress

JUNE 16, 2025

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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Medical Xpress

JUNE 16, 2025

This cluster of about 20,000 to 40,000 neurons functions like a central watch, coordinating the timing of body functions to follow the 24-hour day. When we cross time zones and experience jet lag, it happens because our internal clock remains set to the old time zone. But the NTU team discovered that it is far more complex.

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GeriPal

JUNE 15, 2023

Alex: And joining us via Zoom, we have Charlotta Lindvall, who is a palliative care physician researcher who studies the intersection of natural language processing and communication data at Dana Farber Cancer Institute, where she also works in clinical informatics. I’m sure this is a subject we will return to, given the rapid progress on AI.

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GeriPal

JULY 21, 2022

We learned this and much more, and I had a great time making engine noises singing the Woody Guthrie song “driving in my car.” . I don’t practice clinically in outpatient settings, and often the folks I’m seeing are there for other kinds of issues. Additional Links: (A to Z – under driving). OT programs). Is it you, Emmy?

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GeriPal

NOVEMBER 21, 2024

Acceptance. All of these are ways we cope with stressful situations. Some we may consider healthy or unhealthy coping strategies, but are they really that easy to categorize? Isn’t it more important to ask whether a particular coping behavior is adaptive or not for a particular person,in a particular time or situation? Amanda, welcome to GeriPal.

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Medical Xpress

JUNE 8, 2025

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. But as the findings from our Canadian study show, we urgently need research to improve long-term health outcomes for children born prematurely. Read the original article.

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GeriPal

MAY 9, 2024

Alex: And Sammy Winemaker, who’s a palliative care physician and Associate Clinical Professor at McMaster University in the Department of Family Medicine, Division of Palliative Care. He was also the one who we have to thank for suggesting this podcast! ABIM MOC credit will be offered to subscribers in November, 2024. Great title.

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GeriPal

MAY 15, 2025

The nudge toward offering comfort care led to more hospice and early comfort-care orders. Is this due to chance alone, given the multiplicity of secondary outcomes examined? We’ve done a podcast already on nudging. Where was it? Alex 01:13 The nudging podcast We’ve done a couple I think. We also had a podcast with. Eric 02:08 Great.

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GeriPal

JUNE 30, 2022

Eric: So we’re going to be talking about dementia and considerations around surgery for individuals with dementia. Before we go into this topic, who has a song request for Alex? It was Remember Me. Was that the title? Alex: I think it’s I Will Remember You. Joel: Yeah, right, I Will Remember You, right. Alex: … Sarah McLachlan.

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GeriPal

AUGUST 1, 2024

Summary Transcript Summary What is a healthy diet and how much does it really matter that we try to eat one as we age? That’s the topic of this week’s podcast with three amazing guests: Anna Pleet, Elizabeth Eckstrom, and Emily Johnston. Emily Johnston is a registered dietitian, nutrition researcher, and Assistant professor at NYU.

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Medical Xpress

JUNE 7, 2025

In clinical trials, no participants who received the injection acquired HIV. None of the participants who received the injections got HIV. That early success helped boost Gileads stock by 73% over the past year, The Wall Street Journal reported. "We Consider supporting Science Xs mission by getting a premium account.

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FDA Law Blog

NOVEMBER 8, 2023

Following this, in June 2016, the National Academies of Sciences, Engineering, and Medicine (NASEM) made a similar recommendation of creating a new category of OTC “wearable hearing devices.” Koblitz & Philip Won — The first anniversary is always special. When FDA released the final rule, it outlined its ambitious goals.

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