StorytellERdoc

MARCH 1, 2019

I can't pinpoint the moment exactly, but several years ago I began to notice that many of our ER patients were presenting for treatment wearing nice fluffy fleece bottoms. Most of these earlier bottoms for the younger patients were of superheroes and childhood figures, like kitties and ponies. So were Mom, Dad, and her older brother.

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ER Families Family IT 100

Minnesota Academy of Family Physicians

MAY 6, 2025

It will connect with other interested parties, including representatives from the interpreter and patient communities, to work on answering the following questions: What are the biggest barriers for patients in accessing interpreters? Is there a role for MAFP in addressing those barriers — and if so, what are the next steps?

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Physician's Weekly

JUNE 24, 2025

Dribin, MD , of Cincinnati Children’s Hospital Medical Center, and study coauthors. “We The patients ranged in age from 6 months to 17 years (median age, 7.9 of the patients required an additional epinephrine dose after 2 hours. years); 43.9% were female and 22.0% identified as Hispanic. The incidence fell to 1.9%

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Annals of Family Medicine

NOVEMBER 20, 2024

Context: The COVID pandemic disrupted global healthcare, impacting academic medical centers (AMCs) in the United States, necessitating a comprehensive understanding of its effects on healthcare delivery and utilization. Study Design: This retrospective case series analysis utilizes Vizient’s clinical database data. compared to 2.1

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Myriad Genetics

MAY 20, 2025

Whitnee Brown, a PMHNP and Doctor of Nursing Practice in Birmingham, Alabama, and her patient Lisa Roberts of Huntsville, shared their stories in support of the survey results, which can be viewed here.  The GeneSight test gives me insights and takes out some of the guesswork associated with prescribing mental health medications.”

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The Clinical Problem Solvers

APRIL 3, 2023

[link] CPSolvers: Anti-Racism in Medicine Series Episode 20 – Medical Racism and Indigenous Peoples Show Notes by Sudarshan (“Sud”) Krishnamurthy April 4, 2023 Summary: This episode highlights the checkered past of medicine and the advancements in the field that have occurred at the expense of the humanity of Indigenous peoples.

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StorytellERdoc

FEBRUARY 19, 2019

Several years ago, my daughter Emma introduced me to some videos on YouTube of a dermatologist from California who posted her sometimes shocking but always intriguing encounters with patients who suffered from a variety of dermatologic issues. Yes, white and brown and green and black pus still oozed from the majority of her patients.

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IT ER Patient-Centered Patients 100

Today's Hospitalist

MAY 9, 2025

Since the mid-1990s, our capacity for innovation has never stopped as hospitalists navigate a complex landscape of acute illnesses, interprofessional collaborations and the imperative to provide efficient, high-quality care. But these early systems often struggled with complex medical terminology and the natural flow of conversation.

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The Clinical Problem Solvers

SEPTEMBER 19, 2024

Michelle Ogunwole, MD, PhD, an internist and social epidemiologist who specializes in the care of women with chronic medical conditions and racial disparities in maternal health outcomes, and Dr. Caroline Sloan, MD, a general internist whose research focuses on how financial considerations are imbued into medical decision-making.

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The Clinical Problem Solvers

OCTOBER 18, 2022

All healthcare professionals will have patients who are directly or indirectly impacted by the carceral system. Additionally, our guests urge us to recognize the ways in which our patients are impacted by incarceration and to ask our patients about these impacts in order to better care for them.

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The Clinical Problem Solvers

MARCH 14, 2025

Simon is a pediatric addiction medicine psychiatrist at Boston Children’s Hospital; an assistant professor in psychiatry at Harvard Medical School; a recent Commonwealth Fund fellow in health policy at Harvard University; and the medical director of Wayside Youth & Family Support Network.  2022;31(2):211-221. doi:10.1016/j.chc.2022.01.002

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FDA Law

FEBRUARY 28, 2022

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ).

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Patients Clinic Medical Patient-Centered 52

FDA Law

SEPTEMBER 30, 2022

Valentine — On September 29, 2022, FDA approved Amylyx’s NDA for its drug, Relyvrio (sodium phenylbutyrate/taurursodiol), for treatment of patients with amyotrophic lateral sclerosis (ALS) (see FDA announcement here ). This is evidence of FDA’s embrace of patient-focused drug development. Hyman, Phelps & McNamara, P.C.’s

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FDA Law

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). FDA defines real-world data ( RWD ) as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.” By Jeffrey N.

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Physician's Practice

JUNE 25, 2025

Topics Access and Reimbursement Billing & Collections Coding & Documentation Finance Law & Malpractice MedMal by Coverys Patient Engagement & Communications Staffing & Salary Technology Media Video & Interviews Podcasts Medical World News Pearls Surveys Best States to Practice Great American Physician Survey Staff Salary Survey (..)

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Aspiring Minority Doctor

MARCH 14, 2022

For those who aren’t aware, today is Match Day where thousands of 4th year medical students and graduates find out if they have secured a residency position. For many, this is a joyous day filled with celebrations and sighs of relief, but for the unmatched, this can be one of the most depressing experiences of an entire medical school career.

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FDA Law

AUGUST 12, 2021

As a result of this decision, Semglee can now be substituted for Lantus prescriptions without the intervention of a health care provider in accordance with state substitution regulations. Thus, though Semglee is not new to the market, it is for the first time substitutable for Lantus without intervention of a health care provider.

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FDA Law

OCTOBER 2, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Gail H. If a sponsor is able to provide a detailed description of multiple changes with appropriate performance evaluation methods for each, we hope the Agency will be willing to consider them under a single PCCP.

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The Clinical Problem Solvers

APRIL 24, 2025

Simon is a pediatric addiction medicine psychiatrist at Boston Children’s Hospital; an assistant professor in psychiatry at Harvard Medical School; a recent Commonwealth Fund fellow in health policy at Harvard University; and the medical director of Wayside Youth & Family Support Network.  2019-1187 9. 2022;31(2):211-221.

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PEMBlog

APRIL 22, 2025

While we pride ourselves on providing high-quality care for all children, we must acknowledge that the noisy, fast-paced, and unpredictable environment of the ED can be especially distressing for autistic patients. Discuss options like oral medications, intranasal routes, or the presence of trusted caregivers during procedures.

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Families Family Patient-Centered Physicals 77

FDA Law

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

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The Clinical Problem Solvers

DECEMBER 16, 2020

Our guests explain how we can incorporate race-conscious medicine in clinical settings, medical education, and biomedical/epidemiological research to responsibly recognize and address the harms of racial inequality. Where can you give an extra inch to those for whom you are caring?

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Clinic Education Clinical Practice Patient-Centered 52

FDA Law

OCTOBER 2, 2023

A brief explainer on confirmatory evidence: how we got here Before we dive into the specifics of the new guidance, we should explain that the statutory standard we allude to is the requirement that an applicant provide “substantial evidence of effectiveness” to obtain approval of an NDA or BLA.

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PEMBlog

SEPTEMBER 27, 2023

This is a blog post designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not. isolation for SARS-CoV-2).

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FDA Law

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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Medical Electronics Manufacturing Utilities 64

FDA Law

JUNE 23, 2021

Valentine — For the last 13 years, this blogger has been at the center of what has now been dubbed “patient-focused drug development.” For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. By James E.

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FDA Law

OCTOBER 11, 2022

Additional guidance on confirmatory evidence is sorely needed as the December 2019 draft guidance spends just two of its 18 pages telling us what FDA thinks of such a key piece of statutory language. Since 1962, the Act has given FDA authority to reject a drug application that fails to provide substantial evidence of effectiveness.

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Clinic Provider IT Patient-Centered 61

FDA Law

MAY 8, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. In February 2020, FDA granted a de novo classification request (DEN190040) for software intended to assist medical professionals in the acquisition of cardiac ultrasound images and that included a PCCP for future software modifications.

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FDA Law

OCTOBER 14, 2021

Food and Drug Administration (FDA) is reminding patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention or treatment of breast cancer have not been established. But these devices are not independent cancer therapeutics.

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Patient-Centered Healthcare Manufacturing Provider 52

FDA Law

NOVEMBER 6, 2022

In its petition filed earlier this month, Pfizer challenges HHS’s interpretation of the AKS as “staggeringly overbroad,” contrary to the congressional intent behind the AKS, and a threat to “almost any activity that facilitates patient access to federally funded healthcare.”

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Manufacturing Patient-Centered Healthcare Utilities 83

BMJ

JULY 17, 2020

7 Moreover, medical professionals, health practitioners, and relevant academic institutions should proactively disseminate creditable news and information during such health outbreaks through mainstream social media channels. Psychological health during the coronavirus disease 2019 pandemic outbreak. J I AIDS Soc 2020;23(5): e25504.

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FDA Law

APRIL 11, 2022

Medtronic Warning Letter) provides an important reminder from FDA as to the correct estimation of risk associated with malfunctions. It would seem, though, that FDA is right that total shipments of affected product could potentially overstate the number in actual use by patients, thereby underestimating the risk.

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Medical Management Manufacturing Patients 40

FDA Law

JUNE 28, 2021

If enacted, Article 5, Section 6 of HF33 would provide for a reduction to the State’s opiate product registration fee. For the purposes of assessing the annual opiate product registration fee, a “unit” means “the individual dosage form of the particular drug product that is prescribed to the patient. 151.066, Subd.

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FDA Law

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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FDA Law

JUNE 22, 2022

This matter is the latest in a recent string of large monetary settlements between the government and health care providers involving employee diversion. Lax Controls Provided Employees with Opportunity to Divert. In short, the employees were provided the opportunity to not only commit the crimes but that they went undetected.

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FDA Law

FEBRUARY 7, 2022

FDA proposed to remove dipyridamole and multiple other substances from the list in 2019 ). Unlike the lists for Section 503A formal notice and comment rulemaking is not required. See Section 503A(d). FDA published its notice about its review — and proposed inclusion and/or exclusion — of all but one of these substances in July 2020. (FDA

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FDA Law

FEBRUARY 27, 2024

For years after the enactment of the Hatch-Waxman Amendments the PTO interpreted the PTE statute to permit multiple PTEs, provided there are separate, but not necessarily different, regulatory review periods. See Lourie, Patent Term Restoration: History, Summary, and Appraisal, 40 Food, Drug, and Cosm. 351, 355-56 (1985).

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