FDA Law Blog

NOVEMBER 26, 2024

The NPRM was consistent with the Department of Health and Human Services’ finding that marijuana has a currently accepted medical use in the U.S. Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed. 44,597 (May 21, 2024). and its views about abuse potential and physical or psychological dependence. 70,148, (Aug.

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Pamela Wible MD

MAY 21, 2025

Sponsorships available for medical students and residents. Your retreat includes: Daily spa treatments and gourmet meals delivered to your hot tub A personalized business launch plan: from fee structure to client contracts Search-engine-optimized website copy and marketing strategy 20 hours of bonus Live Your Dream Fast Track training —free!

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Physicians News Digest

MAY 12, 2025

Dr. Lee received her Bachelor’s degree from Seoul National University and Masters and Doctoral degree from Stanford University, all in Electrical Engineering. As new discoveries emerge, brain science is poised to become a key driver of the next great era of innovation: the 5th Industrial Revolution.

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Medical Xpress

DECEMBER 15, 2022

Scientists at UC San Francisco (UCSF) have engineered T cells to produce a potent anti-cancer cytokine, but only when they encounter tumor cells. The immunotherapy eliminated melanoma and pancreatic cancer in mice without major side effects, and it offers a promising new strategy for fighting these and other hard-to-treat cancers.

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The Physicians Foundation

FEBRUARY 14, 2025

Misplaced Training Dollars: Lack of funding for community-based training impacting the primary care physician pipeline Hospital-based graduate medical education (GME) receives significantly more funding than community-based programs, a disparity linked to fewer new primary care physicians entering the workforce. Key findings include: 1.

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Medical Xpress

DECEMBER 22, 2022

Research from Drexel University's School of Biomedical Engineering, Science and Health Systems recently demonstrated that OpenAI's GPT-3 program can identify clues from spontaneous speech that are 80% accurate in predicting the early stages of dementia.

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Permanente Medicine

MAY 20, 2025

Khang Nguyen, MD, chief transformation officer of the Southern California Permanente Medical Group, discusses how AI can increase clinicians’ joy in medicine and improve patient outcomes with Chris Grant, chief operating offer and executive vice president of Kaiser Permanente, The Permanente Federation, and host of the Permanente Medicine Podcast.

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The Medical Futurist

MAY 18, 2025

For years at The Medical Futurist, we’ve covered countless digital health devices and technologies, and how they can empower patients in the digital health age. In the US, some biohacking activities are illegal such as agrobacterium-engineered plants and soil bacteria cultures. What is biohacking?

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Medical Xpress

APRIL 4, 2023

Joe Dituri, a former US navy diver and expert in biomedical engineering has been living in a 55 square meter space 30 feet below the surface of the Florida Keys since March 1, and plans to stay for 100 days. As nightmares go, being trapped in a small box deep underwater is probably high on many peoples' lists.

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Medical Xpress

MARCH 15, 2023

Researchers in the labs of Laurie Cutting, Patricia and Rodes Hart Professor and professor of special education at the Peabody College of education and human development, and Bennett Landman, professor and chair of the Department of Electrical and Computer Engineering at the School of Engineering, published a study in January in Magnetic Resonance (..)

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Medical Xpress

DECEMBER 20, 2024

What does it take to design a new needle for medical use? When the needle needs to be much thinner and sharper than any commercially existing needle and designed to deliver treatments to a previously inaccessible tissue, the answer is years of collaboration between a close-knit team of physicians and engineers.

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FDA Law Blog

FEBRUARY 7, 2023

Lenz, Principal Medical Device Regulation Expert — For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market. Part 830), post-market surveillance studies (Section 522 of the FD&C Act), medical device tracking (21 C.F.R.

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Medical Xpress

APRIL 28, 2023

Paulson School of Engineering and Applied Sciences (SEAS) scientists who discovered this were also amazed at the finding. Would it surprise you to learn that short-term motor memories that last less than a minute play a bigger role than long-term ones in relearning movements after you've forgotten them?

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Medical Xpress

MARCH 2, 2023

It's a familiar story: you feel a twinge in your back and next thing you know, you can't get out of bed. From back pain to achy joints, musculoskeletal pain, while common, can be life-changing and debilitating. But does it have to be?

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FDA Law Blog

FEBRUARY 9, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. By Adrienne R.

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FDA Law Blog

JANUARY 5, 2022

Lenz has become its first Principal Medical Device Regulation Expert. She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical. Hyman, Phelps & McNamara, P.C. (HP&M) HP&M) is pleased to announce Adrienne R. Adrienne joined HPM in September 2017.

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Medical Xpress

FEBRUARY 10, 2023

of the Yale School of Engineering and Applied Science, addresses new quantitative approaches to better define and measure these defects in gene function, known as epigenetics, and their interplay with the genetic landscape of cancer. It is now widely understood that cancer is a disease of acquired defects in genes and gene function.

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FDA Law Blog

JANUARY 2, 2022

Lenz, Principal Medical Device Regulation Expert — On December 23, 2021, CDRH released as a draft guidance, Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions (Draft Guidance). Draft Guidance at 5.

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Medical Xpress

FEBRUARY 21, 2023

The approach was developed and validated by Hokkaido University environmental engineer, Masaaki Kitajima, and colleagues in Japan. A new mathematical model uses wastewater samples to effectively forecast the number of clinical COVID-19 cases in a community five days in advance.

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FDA Law Blog

JANUARY 5, 2022

Lenz has become its first Principal Medical Device Regulation Expert. She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical. Hyman, Phelps & McNamara, P.C. (HP&M) HP&M) is pleased to announce Adrienne R. Adrienne joined HPM in September 2017.

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FDA Law Blog

FEBRUARY 19, 2024

Loloei tackled legal matters related to various aspects of the regulation of medical devices, in vitro diagnostics, and combination products including regulatory and compliance issues, dispute resolutions between the FDA and sponsors, and FDA enforcement actions. During her FDA tenure, Ms. Gibbs , HP&M Director.

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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. No matter if it’s through medication, therapy, lifestyle changes, or often a combination, managing depression can translate to measurable heart health gains. However, chronic stress keeps your body in a continuous state of high alert.

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FDA Law Blog

JANUARY 2, 2022

Lenz, Principal Medical Device Regulation Expert — On December 23, 2021, CDRH released as a draft guidance, Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions (Draft Guidance). Draft Guidance at 5.

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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. Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec.

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FDA Law Blog

NOVEMBER 5, 2023

Dr. Won will share his expertise and insights on the intricacies of the United States Food and Drug Administration (FDA) regulations pertaining to medical devices, with a special focus on class II and class III hearing devices. Philip Won , of Hyman, Phelps & McNamara, P.C.

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FDA Law Blog

DECEMBER 6, 2023

FDA tries to justify the proposed rule by claiming that LDTs present significant risks, and that the solution is to regulate them all as medical devices. Part 11, the need to hire new laboratory personnel, and engage outside experts such as Contract Research Organizations, biostatisticians, lawyers, and software engineers.

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Medical Xpress

MARCH 7, 2023

If it were up to engineering, everything would be optimized. Efficiency would rule, and the best available outcomes would frictionlessly elevate scientific research, live at our fingertips and shape our surroundings.

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FDA Law Blog

JULY 10, 2023

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. By Philip Won & Adrienne R. The stakes are high.

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GeriPal

MAY 5, 2022

Think about the last time you attended a talk on communication skills or goals of care discussions. Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? I’m guessing not. COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. Alex: (Singing).

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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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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. I refer to this thought transference as the Bathroom Experience (BE), a powerful metaphor for how seemingly minor details can dramatically impact patients’ perceptions of a medical practice. But a dirty one?

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Medical Xpress

FEBRUARY 7, 2023

Patients usually receive FVIII that comes from donor blood or is produced using genetic engineering. In hemophilia A cases, the body either partially or completely lacks the blood coagulation factor VIII (FVIII), or the factor is formed incorrectly.

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FDA Law Blog

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

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The Medical Futurist

JUNE 21, 2025

Matthew Enevoldson, PR Manager at SkinVision told The Medical Futurist that technology such as their own is becoming more integrated within the health system, to both ensure that those who need treatment are made aware of it and that those who have an unfounded concern do not take up valuable time and resources.

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StorytellERdoc

MAY 7, 2020

The engine is cut. He signs off the last of information on his seventh patient to his replacement, sharing the important medications, vitals, activities, and care-plan in depth. Uniquely, I have had the pleasures and memories of working beside so many incredibly talented nurses as I traveled through medical school and residency.

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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. Food and Drug Administration (FDA). The process could take years. Ibogaine is made from the root of a plant found in Africa. It has been banned in the U.S. Former Texas Gov.

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The Clinical Problem Solvers

JULY 14, 2021

Below are some questions that CPSolvers ARM host Dr. What is keeping you from being your authentic self? References National Academies of Sciences, Engineering, and Medicine 2020. Promising Practices for Addressing the Underrepresentation of Women in Science, Engineering, and Medicine: Opening Doors. Blackstock, U. N Engl J Med.

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