PEMBlog

JUNE 18, 2025

This multicenter retrospective study aims to provide evidence-based guidance by determining when the risk of repeat epinephrine administration becomes acceptably low. Patients were stratified by initial severity: No respiratory or cardiovascular involvement Respiratory involvement only Cardiovascular involvement Key Findings Overall 4.7

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The Medical Futurist

JUNE 17, 2025

Just like in the case of other medical specialties , disruptive innovations will have a huge impact on how dentistry will be practiced and how patients will take care of themselves in the future. For patients, it promises more accurate care and better outcomes. How about having a teledentist consultation?

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Patients Treatment Plan Healthcare Medical Specialty 126

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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CDOCS

MARCH 15, 2021

png]</p> <p><span style="font-family:ubuntu; font-size:12px">​</span><span style="font-size:14px"><span style="font-family:ubuntu">By putting ourselves in the shoes of our patients, we can easily see the comfort and trust our patients have developed with their general dentists.

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Patients Finance Education Utilities 52

The Clinical Problem Solvers

DECEMBER 16, 2020

Nwamaka Eneanya and Jennifer Tsai to discuss the limitations and harms of race-based medicine in clinical practice. 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.

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Clinic Education Clinical Practice Patient-Centered 52

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. Yet this expansion has come with a significant administrative burden, particularly that of clinical documentation.

Patient-Centered 52

Patient-Centered Telemedicine Clinic Electronics 52

Annals of Family Medicine

NOVEMBER 20, 2024

Objective: To assess the epidemiology and mortality risk among patients discharged from AMCs General Medicine Service Lines in the US from Oct 2019 to Dec 2023. Study Design: This retrospective case series analysis utilizes Vizient’s clinical database data.

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Common Sense Family Doctor

DECEMBER 14, 2024

Concerns about overdiagnosis of clinically insignificant prostate cancer through prostate specific antigen (PSA) screening motivated the 2018 American Academy of Family Physicians’ (AAFP) recommendation against routine screening for prostate cancer. Watchful waiting refers to clinical observation only. A recent analysis of the U.S.

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Routine Screenings Screening Complication Diagnose 52

The Clinical Problem Solvers

OCTOBER 18, 2022

All healthcare professionals will have patients who are directly or indirectly impacted by the carceral system. Our guests remind us to think critically about our role in the carceral system and in imposing systems of control and punishment within clinical settings.

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Healthcare Professional Healthcare Patient-Centered Mental Health 52

The Clinical Problem Solvers

MARCH 14, 2025

Dr. Benton mentors clinical and research physicians, fellows, and postdoctoral trainees. Clinically, he cares for youth and families through the Department of Psychiatry & Behavioral Sciences and the new Division of Addiction Medicine at Boston Children’s Hospital. Child and Adolescent Psychiatric Clinics of North America.

Mental Health 52

Mental Health Community Patient-Centered Hospital 52

The Clinical Problem Solvers

SEPTEMBER 19, 2024

Episode Learning Objectives After listening to this episode, learners will be able to… Understand how they can better center patient experiences by engaging with, and conducting their own, qualitative research. Describe the positive impacts of qualitative methods on healthcare provision and/or policies in clinical settings. Zakaria, S.,

Internal Medicine 52

Internal Medicine Patient-Centered Specialization Community 52

FDA Law Blog

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 Blog

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. By Frank J. Sasinowski & James E.

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FDA Law Blog

MAY 13, 2024

FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices. RWE is “the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.”

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FDA Law Blog

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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The Clinical Problem Solvers

APRIL 24, 2025

Dr. Benton mentors clinical and research physicians, fellows, and postdoctoral trainees. Clinically, he cares for youth and families through the Department of Psychiatry & Behavioral Sciences and the new Division of Addiction Medicine at Boston Children’s Hospital. Child and Adolescent Psychiatric Clinics of North America.

Mental Health 52

Mental Health Community Hospital Appointment 52

FDA Law Blog

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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Clinic Medical Provider Patients 52

FDA Law Blog

OCTOBER 2, 2023

The eagerly anticipated guidance, Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence (i.e., Instead, FDA’s determination of whether a single study plus confirmatory evidence could provide substantial evidence is to be “based on relevant science.”

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FDA Law Blog

OCTOBER 11, 2022

For the past two years, CDER’s Guidance Agenda has included a spot for this eagerly anticipated guidance, tentatively titled ‘Meeting the Substantial Evidence Standard Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence’. Some may confuse this requirement for two studies as a need for replication.

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Clinic Provider IT Patient-Centered 61

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. for bronchiolitis and 1.5%

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Patients Illness Hospital Management 52

FDA Law Blog

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. The practice of medicine was viewed as paternalistic.

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Patients Patient-Centered Clinic IT 52

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. Advocate for transition planning resources as patients age out of pediatric care. 2019-1895L. Pediatrics.

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Family Families Patient-Centered Physicals 80

PEMBlog

MARCH 4, 2025

Well cover its clinical presentation, epidemiology, diagnostic approach, and management, including why standard beta-lactam antibiotics wont work. Learning Objectives Describe the clinical presentation, epidemiology, and complications of Mycoplasma pneumoniae infections in pediatric patients, including its atypical manifestations.

Patient-Centered 93

Patient-Centered Diagnosis Complication Community 93

The Clinical Problem Solvers

APRIL 3, 2023

While some have the impression that there is a safety net in Canada for life-saving medications, Nav still sees patients in his practice who are harmed by the system and not able to afford life-saving medications, many of them Indigenous, and this is a violation of their right to access essential medicines. Can J Public Health. J Biocommun.

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Medical Healthcare Individual Community 52

FDA Law Blog

OCTOBER 14, 2021

Rather, FDA seems intent on regulating RAS devices almost as if they were therapeutics responsible for long term clinical outcomes. RAS devices have been cleared for use in certain types of surgical procedures commonly performed in patients with cancer, such as hysterectomy, prostatectomy, and colectomy. The question answers itself.

Patient-Centered 52

Patient-Centered Healthcare Manufacturing Provider 52

FDA Law Blog

MAY 8, 2023

FDA recommends that PCCPs specify only a “limited number” of modifications but does not provide a limit on the number of modifications that can be included. If the proposed performance evaluation methods are different from the original methods used, the manufacturer should describe the differences and provide a justification for the changes.

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Manufacturing Provider Medical IT 98

FDA Law Blog

SEPTEMBER 11, 2023

This announcement addresses one of the commitments in FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health. FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs.”

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Medical Electronics Manufacturing Utilities 64

FDA Law Blog

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers. FDA’s position is, however, only one side of the story.

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Manufacturing Hospital Healthcare Medical 81

FDA Law Blog

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s blog here. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. §

Lab Testing 52

Lab Testing Individual Referral Patient-Centered 52

FDA Law Blog

MARCH 1, 2023

By way of background, FDA first proposed using a QMM rating in its 2019 Report on Drug Shortages and Potential Solutions. The report recommends using a QMM rating that is shared throughout the market (purchasers, consumers, competing manufacturers) to provide manufacturers committed to QMM with a competitive advantage.

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Management Manufacturing Supply Chain Provider 45

FDA Law Blog

SEPTEMBER 29, 2021

Department of Health and Human Services (“HHS”), which reported that discounted purchases totaled $38 billion in 2020, a 27% increase compared to 2019. Use of contract pharmacies ballooned after a guidance issued by HRSA in 2010 allowed covered entities to use multiple contract pharmacies to dispense drugs to covered entity patients.

Manufacturing 52

Manufacturing Government Referral Provider 52

FDA Law Blog

SEPTEMBER 15, 2022

Interestingly, in the 2019 proposal for sunscreen labeling, FDA proposed to require a size at least one quarter the size of the most prominent printed matter). Interestingly, it provides information for manufacturers who want to include (voluntarily) the phosphorus level in the drug product.

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Manufacturing Hypertension IT Provider 45

FDA Law Blog

MAY 17, 2022

FDA approved FIRDAPSE in November 2018, with a period of orphan drug exclusivity, for the treatment of Lambert-Eaton Myasthenic Syndrome (“LEMS”) in adult patients. But in May 2019, FDA approved a second amifampridine drug product, Jacobus Pharmaceutical Company, Inc.’s and more likely 15-20. Becerra.”

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IT Patients Individual Provider 40

FDA Law Blog

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s blog here. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. §

Lab Testing 40

Lab Testing Individual Referral Patient-Centered 40

Annals of Family Medicine

NOVEMBER 20, 2024

A US-based study conducted by the Kaiser Family Foundation found 69% of patients reported avoiding discussions about death, but 92% reported feeling somewhat comfortable talking to a heath care provider about EOL wishes. Setting or Dataset: Outpatient palliative care cancer clinic at a tertiary health care center in the U.S.

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Patients Patient-Centered Provider Education 130

Annals of Family Medicine

NOVEMBER 20, 2024

Context: Appropriate use of medication is a key indicator of the quality of care provided in long-term care (LTC). Using linked administrative databases, we identified all instances of PIP-AP according to the STOPP-START criteria, which have previously been shown to predict adverse clinical events such as ED visits and hospitalizations.

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Patients Provider Individual Hospital 130

GeriPal

FEBRUARY 27, 2025

Substance use disorder is one of those complex issues in which clinical practice is changing rapidly. We address: Why is caring for patients with this overlap so hard? Sach Kale set up an outpatient clinic focused on substance use disorder for patients with cancer. See Sachs write up about setting up this clinic in JPSM.

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Patients Clinic Patient-Centered Illness 73