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. Our providers offer compassionate care and practical lifestyle counseling personalized to your specific needs.

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FDA Law Blog

FEBRUARY 7, 2023

Part 814), and for conducting clinical trials (21 C.F.R. There are many resources that provide information and guidance for each of these required elements. 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.

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Permanente Medicine

MAY 20, 2025

” “Whether you’re the call center agent, the receptionist, [or] the lab tech, you participate and you provide the input into innovation,” said Dr. Nguyen. The Southern California Permanente Medical Group is one of the largest medical groups in the nation with more than 8,800 physicians providing care for over 4.8

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FDA Law Blog

DECEMBER 15, 2024

In eight pages we get a string of high-level regulatory questions that provide a nice roadmap for CMC product development, which largely align with opportunities to engage with CBER as you progress through the development of cellular and gene therapies (CGT). What can be gained from this new guidance from a CMC perspective is more nuanced.

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FDA Law Blog

OCTOBER 10, 2023

Testing should be in line with the device’s intended duration of implantation, but FDA may consider whether testing results for a shorter duration can be extrapolated to provide information about long-term performance. In cases where devices are expected to be frequently replaced, testing should be guided by the aggregate patient exposure.

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FDA Law Blog

JULY 10, 2023

By Day 100 If MDUFA Decision is not reached by Day 100, FDA provides Missed MDUFA Decision Communication that identifies outstanding review issues. These AI requests often address complicated scientific scenarios in which a submitter has already provided some information, but FDA is not completely satisfied.

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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

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.”. Draft Guidance at 5. Calculation verification determines the solution accuracy of a calculation.

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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.”. Draft Guidance at 5. Calculation verification determines the solution accuracy of a calculation.

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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? COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. And he is also a clinical audiologist, which is going to be key for this podcast. I’m guessing not. Transcript.

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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. The content is provided for information purposes only.

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Medical Xpress

JUNE 16, 2025

DOI: 10.1038/s41467-025-58661-1 Journal information: Nature Communications Provided by National Taiwan University Citation : Rewiring the body clock: Deep brain imaging reveals unexpected complexity in jet lag adjustment (2025, June 16) retrieved 16 June 2025 from [link] This document is subject to copyright. Your feedback is important to us.

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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).

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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 think the AI can allow for that complexity but still provide some guidance.

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Medical Xpress

JUNE 8, 2025

While many of these procedures provide critical care, we know they are acutely painful. 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. The content is provided for information purposes only. Read the original article.

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GeriPal

NOVEMBER 21, 2024

The clinical trials and the this and that. Well, maybe they’re an engineer and understanding makes them feel rooted. And she says, no, I heard that there’s a clinical trial at the Mayo Clinic, and I’m wondering about this. And when they’re in their treatment phase, that’s really serving them.

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GeriPal

MAY 9, 2024

Why focus on the public rather than other health care providers? 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. I do think other healthcare providers need to learn about this.

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GeriPal

JUNE 30, 2022

So when I was a resident at Cleveland Clinic, I got to see really cutting-edge technology, some of the best surgeons in the country, and perhaps in the world, operating on patients. Eric: Let’s say tomorrow, a patient comes into your clinic. Eric: Mm-hmm. Eric: How about you, Samir? Eric: So Samir, you’re a surgeon, right?

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GeriPal

MAY 15, 2025

At one end of the spectrum you can provide decision makers with information that doesn’t work very well in most contexts. Ultimately, it’s not a study of palliative care clinicians per se, but it’s a study of the construct of providing high quality palliative care. I think it’s good to place nudges in context.

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GeriPal

AUGUST 1, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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Medical Xpress

JUNE 7, 2025

The content is provided for information purposes only. In clinical trials, no participants who received the injection acquired HIV. Citation : Long-lasting HIV prevention shot headed toward approval (2025, June 7) retrieved 9 June 2025 from [link] This document is subject to copyright. Your feedback is important to us.

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FDA Law Blog

NOVEMBER 8, 2023

The rule also aimed to provide “consumers with perceived mild to moderate hearing loss with improved access to devices that meet their needs and are less expensive than current options.” Yet the milestone should not pass without recognition, and it provides a great opportunity for objective evaluation.

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