FDA Law Blog

OCTOBER 16, 2023

Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Javitt & Steven J. Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products.

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Logansport Memorial Hospital

MARCH 7, 2024

It’s important to be able to trust your caregivers, and here at Logansport Memorial, we go above and beyond to develop relationships with our patients and provide personalized, high-quality care for our community. But 2023 was a really bad year for me between the infection and everything. But then I got the flu.

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PEMBlog

JUNE 7, 2023

There are protocols in place that assist highly trained Emergency Medical Service providers in assuring that agitated children are safely transported to their destination. Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together.

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FDA Law Blog

DECEMBER 7, 2023

There were too many interesting panels and discussions to mention them all, but presentations about DOJ’s and FDA’s coordination deserve some special mention. In his conference keynote address , Arun Rao—the Deputy Assistant Attorney General for DOJ’s Consumer Protection Branch—provided an overview of DOJ’s year in FDA enforcement.

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FDA Law Blog

MAY 19, 2023

In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device. The Special Controls are silent on what would constitute appropriate levels of evidence necessary to satisfy this criterion. analytical, clinical and stability).

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FDA Law Blog

OCTOBER 6, 2023

The amended regulation would read as follows (revisions underlined): In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.

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FDA Law Blog

AUGUST 18, 2024

The De Novo process provides a regulatory pathway to classify novel devices for which general controls alone or general and special controls provide reasonable assurance of safety and effectiveness for the intended use. The classification order identifies the special controls and therefore is extremely important.

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FDA Law Blog

NOVEMBER 6, 2024

Starting in 2022 with a patent certification requirement, both Jazz and Avadel have sued FDA over this drug, with Jazz most recently bringing suit challenging FDA’s decision that Avadel’s Lumryz (sodium oxybate) is clinically superior to Jazz’s Xywav (sodium oxybate) in 2023. This case followed. The Court held that it does.

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FDA Law Blog

JULY 17, 2024

Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations. those reviewed by the CDER Division of Rare Diseases and Medical Genetics).

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Aspiring Minority Doctor

FEBRUARY 7, 2023

I’m actually about to land soon and can barely keep my eyes open as I’ve been traveling since yesterday, but I wanted to get this started so that I can finish and hopefully post tomorrow. I figured I didn’t have a chance in hell at winning, but I shared anyway because 1) I’m always happy to share my story with hopes that it uplifts/inspires others.

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FDA Law Blog

FEBRUARY 27, 2023

That emergency declaration is set to expire on May 11, 2023. While no “special registration” will yet be required to engage in telemedicine prescribing of controlled substances, DEA is proposing parameters to guide the practice of telemedicine encounters in a post-COVID world. 21 U.S.C. § 802(54)(D)(i). 21 U.S.C. § 802(54)(D)(i).

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FDA Law Blog

MAY 8, 2023

See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a) a) , and related guidance documents (e.g., here for a 510(k) device and here for a PMA device). The draft guidance follows the December 2022 enactment of the Food and Drug Omnibus Reform Act of 2022 (FDORA).

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The Clinical Problem Solvers

DECEMBER 16, 2020

Fields Time Stamps 00:00 Mission, vision, and introductions of hosts 01:30 Background on three-episode series 02:26 Introductions of guests 04:16 How Dr. Tsai has seen race-based medicine play out in clinical practice 10:45 What role should race play in making clinical decisions?

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FDA Law Blog

MAY 4, 2023

In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories. With regard to clinical trial visits and activities, the draft guidance provides examples of the types of approaches that may be possible with a DCT.

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FDA Law Blog

FEBRUARY 22, 2023

as a de novo special control or in a guidance document for a specific device type). To justify an expansion of the 510(k) burden of this magnitude, FDA needs to provide a clear and detailed accounting of what the problem is, the cost of this change, and why it will improve safety without hindering the development of better devices.

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PEMBlog

AUGUST 20, 2024

2023; 187:109792. eCPR is typically performed in specialized centers with highly trained personnel in well coordinated teams. ECPR involves using ECMO (Extracorporeal Membrane Oxygenation) to take over heart and lung functions, offering a last-resort option that is becoming more common in large pediatric hospitals. Am Heart J.

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PEMBlog

APRIL 20, 2023

A special thanks to Dr. Cristina Tarango, director of the Hemophilia Treatment Center at Cincinnati Children’s and Lisa Littner, Project Manager at Cincinnati Children’s who helped me research and write this post. …and it’s called Hemlibra (Emicizumab) Why this med is important and why kids are on it?

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FDA Law Blog

FEBRUARY 28, 2023

FDA announced on October 3, 2022 that the voluntary electronic Submission Template And Resource (eSTAR) templates would be required beginning October 1, 2023, as we blogged about here. There are additionally places to provide attachments for test reports and other supporting documents. Learnings on how eSTAR works Starting Too Early.

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Doctors for America

MAY 15, 2025

– The Substance Abuse and Mental Health Services Administration (SAMHSA) provides critical support for Americans suffering from mental health conditions. Nearly 50,000 people died by suicide in 2023 and another 12.8 This line provides life-saving care for some of our most vulnerable populations.

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Physician's Weekly

JUNE 19, 2025

The number of nurse practitioners specializing in geriatrics has more than tripled since 2010, increasing the availability of care to the current population of seniors, a recent study in JAMA Network Open found. “We step into places where other providers may not, and geriatrics is a prime example of that.”

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FDA Law Blog

OCTOBER 30, 2023

Houck — The Drug Enforcement Administration (“DEA”) has issued its notice finalizing updates to its longstanding Special Surveillance List of chemicals and equipment used in the illicit manufacture of controlled substances and listed chemicals. DEA’s notice of updates with the Special Surveillance List is attached here. By Larry K.

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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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FDA Law Blog

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. Below, we provide a high-level summary of the Final Guidance, focusing on the legal and regulatory updates from the May 2023 draft guidance.

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Medical Xpress

JUNE 16, 2025

What is known is that special cells in the eye called intrinsically photosensitive retinal ganglion cells (ipRGCs) detect blue light and send signals to the SCN to reset the clock. When we cross time zones and experience jet lag, it happens because our internal clock remains set to the old time zone.

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FDA Law Blog

JUNE 26, 2023

Houck — The Drug Enforcement Administration (“DEA”) has designated precursor chemicals, including 4-piperidone just last month, used in the illicit manufacture of controlled substances as List I and II chemicals over the years as “laboratory supplies,” but has never revised or updated its Special Surveillance List. 39,479, (June 16, 2023).

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Physician's Weekly

JUNE 19, 2025

About 3 in 10 adults reported not taking their medicines as prescribed at some point between July 2022 and July 2023 because of the cost, according to a KFF survey. So, this year, “An Arm and a Leg” asked listeners: What strategies have you used when you’ve been struck by pharmacy sticker shock? He left without it.

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GeriPal

MARCH 24, 2023

JAMA IM 2023 A shout-out to my NPR episode on 1A titled the “State of Hospice Care” DISCLAIMER While we filmed in Montreal during the Annual Assembly, all opinions expressed in this podcast are independent of AAHPM and HPNA, or the Annual Assembly. JAMA IM 2021 Hospice Acquisitions by Profit-Driven Private Equity Firms. JAMA Health Forum.

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The Motivated MD

SEPTEMBER 19, 2024

’ Though it often does not come with the attending salary, medical trainees are getting paid to perform a service, and hospitals provide retirement plans to these individuals. Saving $23,000 when the national average unweighted resident salary in 2023, according to AAMC data , was $63,800. So yes, humans make mistakes.

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FDA Law Blog

JULY 29, 2024

Newberger — In November 2023, FDA published a proposed rule regarding wound products containing antimicrobials. Without providing a single piece of evidence, the premise of the proposed rule is that these wound products with antimicrobials are contributing to the spread of antimicrobial resistance (AMR). By Jennifer D.

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GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. It’s there.

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Illness IT Patient-Centered Patients 107

ABIM

MAY 30, 2025

The Nephrology Board does not currently have a member who is a private practice general nephrologist and agreed to give special consideration to applicants from non-university, community settings for the next opening that will occur in July 2026. Rodriguez, MD , Chair of the Nephrology Board, and John C.

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GeriPal

FEBRUARY 8, 2024

2023 Dec 20:S1524-9042(23)00202-3. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. Hospital Chaplains, Spirituality, and Pain Management: A Qualitative Study. Pain Manag Nurs. doi: 10.1016/j.pmn.2023.11.004. 2023.11.004. PMID: 38129210.

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PEMBlog

JANUARY 16, 2025

Learn how to recognize and manage cases in the emergency department, ask the right questions to uncover inhalant use, and provide critical resources for prevention and support. Clin Toxicol (Phila) 2023; 61:453. Updated February 26, 2024. Accessed January 13, 2025. link] Hogge RL, Spiller HA, Kistamgari S, et al. Intelligencer.

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FDA Law Blog

APRIL 8, 2024

MRAP would provide oversight of an accreditation body which would conduct assessments—paid for by the manufacturer—based on criteria developed by the MRAP. Unfortunately, the White Paper does not provide further analysis on the generic sterile injectables and instead refers back to FDA’s analysis from 2013-2017. In Section I.A,

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PEMBlog

MARCH 27, 2024

My special guest podcaster, Emily Groopman, is an actual Pediatric Geneticist in training and we hope that you will find this episode useful. Updated 2023 Jul 17]. So my special guest host on this episode is a trainee in pediatrics and medical genetics. You can contact her via email at egroopman@childrensnational.org.

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GeriPal

APRIL 6, 2023

Today we have a star-studded lineup, including Lexy Torke of Indiana University, who discusses her RCT of a chaplaincy intervention for surrogates of patients in the ICU , published in JPSM and plenary presentation at AAHPM/HPNA. It meets in-person, once a month, over nine sessions. First, the lyrics, that’s the main reason why I chose it.

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New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

Eating fruit provides excellent health benefits and is part of a healthy plate. Fruits provide nutrients vital for health and maintenance of your body. Fiber containing foods such as fruits help provide a feeling of fullness with fewer calories. Then take a moment to reflect on your unique plate.

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