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.

Medical 119

Medical Patient-Centered Healthcare Specialization 119

PEMBlog

JUNE 7, 2023

Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. NASEMSO: Clinical care and restraint of agitated or combative patients by emergency medical service practitioners. link] Patient restraint in emergency medical services [Position Statement]. Prehosp Emerg Care.

Transportation 122

Transportation Patient-Centered Management Finance 122

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).

Specialization 40

Specialization Clinic Provider IT 40

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.

Clinic 111

Clinic IT Patient-Centered Consulting 111

PEMBlog

MAY 31, 2023

When we think of managing agitated patients we think of medicines – but that shouldn’t be our first option. Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. However, medications can be adjuncts to non-pharmacologic means to help keep agitated children safe from harm.

Management 89

Management Patient-Centered Finance Transportation 89

FDA Law Blog

JULY 17, 2024

We also commend and congratulate the legions of rare disease patient advocates and the leadership of the EveryLife Foundation for Rare Diseases (“ELF”) who championed the advocacy efforts that led to this important milestone. By Sarah Wicks & James E. Valentine & Frank J.

Patient-Centered 105

Patient-Centered Community Medical Specialty Clinic 105

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.

Specialization 69

Specialization Hospital Physicals Provider 69

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.

IT 52

IT Medical Mental Health Patients 52

PEMBlog

JUNE 14, 2023

Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. Pediatrics March 2023; 151 (3): e2022057383. Boarding of Mentally Ill Patients in Emergency Departments: American Psychiatric Association Resource Document. Nash, Kavita Parikh, Bonnie T. 10.1542/peds.2022-057383 2019.6.42422.

Mental Health 98

Mental Health Management Patient-Centered Illness 98

PEMBlog

MAY 17, 2023

Furthermore, the connection between physical and functional symptoms is inextricably linked in many patients. Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. Diagnostic yield of head CT in pediatric emergency department patients with acute psychosis or hallucinations.

Patient-Centered 68

Patient-Centered Mental Health Management Finance 68

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).

Telemedicine 59

Telemedicine Telecommunication Telehealth Medical 59

The Clinical Problem Solvers

DECEMBER 16, 2020

19:05 Clarifying the “ethics vs science” argument and critiquing research techniques 22:00 Resurgence of race-based speculation in COVID-19-related research 25:57 Implantation of ideas about innate racial inferiority within medicine 28:32 Will removal of race from algorithms potentially harm our patients?

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

Aspiring Minority Doctor

DECEMBER 30, 2022

I'm just seriously so blessed to have such an amazing daughter and I'm even more so grateful that I was able to spend her special day with her and celebrate in a way that she wanted. I am excited for 2023 and for the wild ride I'm sure it will take me on. Yep, the little one turned 16 in November! Can you believe it?!?!

Specialization 52

Specialization IT Individual Patients 52

FDA Law Blog

MAY 8, 2023

The discussion paper described a PCCP as including (1) the types of anticipated modifications (SaMD Pre-Specifications or SPS) based on the retraining and model update strategy and (2) the associated methodology (Algorithm Change Protocol or ACP) being used to implement those changes in a controlled manner to manage patient risks.

Manufacturing 98

Manufacturing Provider Medical IT 98

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. How to know if a patient is on it? Patients on emicizumab will have it listed on their medication list.

Individual 52

Individual Patient-Centered Patients IT 52

PEMBlog

AUGUST 20, 2024

While ECPR shows promise in improving survival rates, particularly in pediatric patients with conditions like congenital heart disease, it is resource-intensive and carries significant risks. 2023; 187:109792. So first, the patient has ongoing, high quality CPR. Am Heart J. 2020;229:29–39. Bartos JA, Yannopoulos D.

Patient-Centered 52

Patient-Centered Hospital Patients IT 52

GeriPal

NOVEMBER 9, 2023

Hot off the presses RCT in JAMA October 2023: Study that looks at 1000 female resident physicians at 26 sites that showed that coaching improved each outcome assessed (burnout, moral injury, imposter syndrome, self-compassion, and flourishing). [link] 2. Summary Transcript Summary Coaching is in. We address: What is coaching? AlexSmithMD 1.

Board-Certified 110

Board-Certified IT Primary Care Referral 110

FDA Law Blog

FEBRUARY 22, 2023

as a de novo special control or in a guidance document for a specific device type). By Jeffrey K. Shapiro — More than a decade ago, FDA began systematically to incorporate review of human factors (HF) design validation within 510(k) reviews. Industry would certainly welcome guidance intended to smooth the HF aspects of 510(k) reviews.

Manufacturing 64

Manufacturing Engineering Medical IT 64

FDA Law Blog

MAY 4, 2023

Section 3606(a) of the Food and Drug Omnibus Reform Act (FDORA) directed FDA to “issue or revise draft guidance that includes recommendations to clarify and advance the use of decentralized clinical studies to support the development of drugs and devices,” not later than December 29, 2023. DHTs include monitoring instruments (e.g.,

Clinic 59

Clinic Telehealth Provider Electronics 59

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.

Provider 64

Provider Manufacturing IT Medical 64

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 two forms: one for non-IVD devices and one for IVD devices. There are two forms: one for non-IVD devices and one for IVD devices.

Provider 52

Provider Electronics IT Complication 52

Physician's Weekly

JUNE 19, 2025

On Fridays, Stephanie Johnson has a busy schedule, driving her navy-blue Jeep from one patient’s home to the next, seeing eight in all. Forget a lunch break; she often eats a sandwich or some nuts as she heads to her next patient visit. “Our patient isn’t just the older adult,” Johnson said. “Hello.

Nurse Practitioner 52

Nurse Practitioner Families Family Primary Care 52

Doctors for America

MAY 15, 2025

Nearly 50,000 people died by suicide in 2023 and another 12.8 Our patients’ lives depend on it. DFA is an organization of over 27,000 physician and medical student advocates in all 50 states, representing all areas of specialization. million calls, texts, and messages since its introduction in July 2022.

Mental Health 92

Mental Health Medical Student Community Provider 92

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.

Mental Health 52

Mental Health IT Medical Specialization 52

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.

Insurance 52

Insurance IT Board-Certified Medical 52

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.

IT 114

IT Provider Patients Families 114

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.

Illness 107

Illness IT Patient-Centered Patients 107

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.

Provider 109

Provider Complication Medical Diabetes 109

GeriPal

FEBRUARY 8, 2024

2023 Dec 20:S1524-9042(23)00202-3. Our guests are BJ Miller, palliative care physician and c-founder of Mettle Health , and Naomi Saks, chaplain at UCSF. Hospital Chaplains, Spirituality, and Pain Management: A Qualitative Study. Pain Manag Nurs. doi: 10.1016/j.pmn.2023.11.004. 2023.11.004. Epub ahead of print. PMID: 38129210. Kleinman, A.

IT 137

IT Families Family Physicals 137

ABIM

MAY 30, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Enhancements made to the LKA in response to feedback from physicians who identified areas for improvement, which are intended to keep the program relevant and effective.

Board-Certified 40

Board-Certified Government Internal Medicine Private Practice 40

GeriPal

SEPTEMBER 5, 2024

And Bill Andereck is still haunted by the decision he made to have the police break down the door to rescue his patient who attempted suicide in the 1980s, as detailed in this essay in the Cambridge Quarterly of HealthCare Ethics. I think the theme is more saving someone’s life and the regret that follows. Bill 01:52 I do. Here we go.

Patients 98

Patients IT Patient-Centered Hospital 98

PEMBlog

MAY 24, 2023

Patient that are agitated should always be treated with dignity and respect. Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. This entails utilizing the least invasive non-pharmacologic means of assisting them, before moving to physical or chemical restraints.

Management 54

Management Patient-Centered Physicals Finance 54

PEMBlog

JANUARY 16, 2025

Formulate effective strategies for identifying, managing, and preventing inhalant misuse in pediatric patients. Clin Toxicol (Phila) 2023; 61:453. As always, Im your host, Brad Sobolewski, and today were diving into an important topic, inhalant misuse, with a special focus on nitrous oxide. References Perry H, Burns MM.

Complication 52

Complication Patient-Centered Management Patients 52

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.

Consulting 59

Consulting Individual Families Family 59

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. These studies are important. It meets in-person, once a month, over nine sessions. The theme is death.

IT 99

IT Patient-Centered Families Family 99

FDA Law Blog

APRIL 8, 2024

In its report, Drug Shortages: Root Causes and Potential Solutions, FDA explains that the equipment needed to produce sterile injectables is highly specialized and expensive, meaning that in a shortage situation, production capacity cannot be substantially increased without taking the time and expense of procuring and qualifying new equipment.

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

Vida Family Medicine

MARCH 1, 2023

This week, February 27-March 5, 2023, marks National Eating Disorder Awareness Week. As a person who has recovered from an eating disorder and a physician who treats many patients who are in recovery, I think it is extremely important to take advantage of this week every year to spread awareness.

Mental Health 52

Mental Health Physicals Family Medicine DO 52