FDA Law Blog

OCTOBER 16, 2023

discusses several approaches that companies are exploring for use of AI in the diagnosis of Alzheimer’s Disease, including AI-enabled software for retinal scans and identification of genetic triggers. The first article—“Is the Eye the Window to Alzheimer’s?”—discusses Meanwhile, FDA’s AI/ML-focused initiatives continue to expand.

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Medical Patient-Centered Healthcare Specialization 119

PEMBlog

JANUARY 21, 2025

Differentiating these pathogens based on clinical presentation is crucial for targeted management, minimizing unnecessary diagnostic tests, and optimizing healthcare resources. Common Complications : Otitis media : Diagnosis is supported by the presence of a bulging tympanic membrane with purulent effusion.

Clinic 52

Clinic Complication Diagnosis Illness 52

PEMBlog

OCTOBER 18, 2023

PEMPix is the American Academy of Pediatrics Section on Emergency Medicine’s annual visual diagnosis competition. Clinical features of neonatal toxic shock syndrome-like exanthematous disease emerging in Japan. 2023; 40( 2): 349- 351. This is the first of the four cases. Lancet (London, England), 351(9116), 1614–1619.

Diagnosis 59

Diagnosis Diagnose Illness Patients 59

Myriad Genetics

APRIL 15, 2024

Mayo Clinic. Published 2023 Jan 6. Prenatal Diagnosis. Prenatal diagnosis of the 22q11.2 DiGeorge syndrome (22q11.2 deletion syndrome) – Symptoms and causes. Accessed February 22, 2024. link] Blagowidow N, Nowakowska B, Schindewolf E, et al. Prenatal Screening and Diagnostic Considerations for 22q11.2 Genes (Basel).

Screening 52

Screening Patient-Centered Diagnosis Healthcare 52

PEMBlog

OCTOBER 26, 2023

“Clinically, Meckel diverticulum should be suspected in any child younger than 2 years of age with painless rectal bleeding. STAT Pearls, 2023 Wrap Up Meckel diverticulum is a congenital anomaly of the small intestine that can present with various clinical manifestations, including rectal bleeding and obstruction. .”

Diagnosis 64

Diagnosis Complication Consulting Management 64

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 91

Patient-Centered Diagnosis Complication Community 91

PEMBlog

MAY 1, 2025

In this episode, we tackle the clinical mischief of Parvovirus B19 , a common viral infection with a surprisingly wide range of manifestationsfrom the classic slapped cheek rash of erythema infectiosum to aplastic crises in children with hemolytic anemias and fetal hydrops in pregnant contacts. link] Edwards, Morven S. UpToDate , Jun.

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Complication Patient-Centered Patients Clinic 83

PEMBlog

FEBRUARY 9, 2024

Just look at the rash – then scroll down to reveal the diagnosis. Your hospital might even have a specific clinic to follow this up – like the PATS – Penciling Allergy Testing Service at Cincinnati Children’s. Updated 2023 Aug 28]. That’s it. The child has fever and swollen feet as well. Serum Sickness.

Diagnosis 52

Diagnosis Family Families Hospital 52

FDA Law Blog

FEBRUARY 27, 2023

That emergency declaration is set to expire on May 11, 2023. 180 days past May 11, 2023) for those telemedicine relationships established during the COVID-19 emergency. Comments, including data from research and clinical practice, that provides evidence that an alternate maximum day supply (other than the proposed 30-day supply).

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Telemedicine Telecommunication Telehealth Medical 59

FDA Law Blog

JUNE 22, 2023

FDA hailed its authorization of the Lucira OTC home test for influenza and COVID-19 as “underscor[ing] the Agency’s continued commitment to increase availability of accurate and reliable at-home diagnostic tests” ( April 2023 FDA Update to CDC ). lay users). seeking treatment).

Manufacturing 59

Manufacturing Clinic IT Transportation 59

PEMBlog

SEPTEMBER 24, 2024

PEMPix is the American Academy of Pediatrics Section on Emergency Medicine’s annual visual diagnosis competition. What’s the Diagnosis? Most patients are afebrile by the third day of treatment and clinically improved within two weeks. 2023 Jul 24. Treasure Island (FL): StatPearls Publishing; 2023 Jan–.

Diagnosis 52

Diagnosis Diagnose Patients Asthma 52

FDA Law Blog

JUNE 28, 2023

By Riëtte van Laack — On June 8, 2023, bipartisan legislation creating a new category of animal feed ingredients, named zootechnical animal food substances, was introduced. On June 15, 2023, an amendment modeled after the Innovative FEED Act, was proposed as an amendment to S.1844

Provider 45

Provider Diagnosis Diagnose Clinic 45

Annals of Family Medicine

NOVEMBER 20, 2024

Objective Describe the population of patients referred to a palliative care clinic and observe their healthcare utilization patterns. Study Design Retrospective chart review of patients seen in a palliative care clinic between June 2023 and August 2023.

Patients 130

Patients Diagnosis Patient-Centered Utilities 130

PEMBlog

SEPTEMBER 6, 2023

Attention to any toxidromes, any abnormal vital signs or mental status, eye findings, and neurologic examination provide the greatest help in narrowing the differential diagnosis. Clinical utility of screening laboratory tests in pediatric psychiatric patients presenting to the emergency department for medical clearance. Ann Emerg Med.

Lab Testing 52

Lab Testing Medical Patients Mental Health 52

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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Provider Manufacturing IT Medical 64

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). We make a diagnosis. AlexSmithMD 1. It’s so different from therapy.

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Board-Certified IT Primary Care Referral 111

Physician's Weekly

JUNE 18, 2025

adults participating in the National Health and Nutrition Examination Survey (2021 to 2023). “The simple and universally accessible waist-to-height measurement is useful in clinical and public health practice for liver disease screening, prevention, diagnosis and management globally.” Agbaje, M.D.,

Diagnosis 52

Diagnosis Screening Management Clinic 52

FDA Law Blog

MARCH 13, 2023

Who better than people living with a condition to inform drug companies, physicians, academics, and the FDA on what it is like to live with their condition, what symptoms most impact their lives, what goes into their decision about whether to participate in a clinical trial, and what kind of treatment effects would be most meaningful to them?

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Patients Patient-Centered Families Family 98

Physician's Weekly

JUNE 11, 2025

The systematic review of peer-reviewed intervention was published from 2018 to 2023. The Southern US accounts for more than half of all new HIV diagnoses, and in Georgia, where I practice, new HIV diagnosis rates in 2022 were seven times higher among Black women than White women and two times higher than among White men.

Mental Health 114

Mental Health Healthcare Professional Community Healthcare 114

Doctor On Demand

APRIL 28, 2025

Urgent care clinics provide quick diagnoses and treatments, including antibiotics if needed. In fact, most sore throat symptoms resolve in three days for 60-70% of patients, according to March 2025 UpToDate, an evidence-based clinical decision support system used by healthcare professionals. Is my sore throat contagious?

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ER Telehealth Primary Care Doctor Appointment 52

FDA Law Blog

OCTOBER 17, 2023

This implies that if device technologies and features can produce a clinically meaningful impact for the treatment or diagnosis of a condition in certain populations, such data could support the case that the device satisfies the first designation criterion. By Philip Won & Lisa M.

Medical 53

Medical Diagnosis Healthcare Clinic 53

FDA Law Blog

JANUARY 18, 2024

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. By Larry K.

Medical 69

Medical Physicals IT Patient-Centered 69

GeriPal

AUGUST 17, 2023

Praised by the FDA, Alzheimer’s Association (AA), and Pharma as a “game changer”, but derided by others for the drug’s lack of clinical efficacy, risk of severe adverse effects, absence of diversity in trial populations, high costs, and an FDA approval process that was in the kindest words “rife with irregularities”. That was an FDA decision.

Patient-Centered 98

Patient-Centered IT Clinic Patients 98

PEMBlog

DECEMBER 14, 2023

Early diagnosis is crucial as it can impact a child’s growth and development. Learn all about diagnosis and management of this common problem in this brief podcast episode. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Laryngomalacia, is the most common cause of infant stridor. Laryngomalacia.

Diagnosis 52

Diagnosis IT Diagnose Patients 52

PEMBlog

MARCH 27, 2024

She is a member of the Clinical Genome Resource Inborn Errors of Metabolism (IEM) Clinical Domain Working Group, where as a biocurator she assesses the pathogenicity of variants in IEM-associated genes to facilitate expedited genetic diagnosis for IEMs. Updated 2023 Jul 17]. On clinical presentation. Pediatr Rev.

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Consulting Individual Families Family 59

GeriPal

FEBRUARY 9, 2023

Amber tells the moving story of how these findings led a clinical colleague, her chief, to question and change his behavior. Alex: We are delighted to welcome Amber Barnato, who’s a palliative care physician and health service researcher, and she’s director of the Dartmouth Institute for Health Policy and Clinical Practice.

Patient-Centered 112

Patient-Centered Patients IT Healthcare 112

FDA Law Blog

SEPTEMBER 30, 2024

Gaulkin — In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP), including a new “price verification survey,” and a controversial proposal to require “stacking” of discounts to different customers when determining best price. Kirschenbaum & Sophia R.

Manufacturing 59

Manufacturing Utilities Provider IT 59

FDA Law Blog

JUNE 2, 2023

For 10 high-cost single source covered outpatient drugs selected annually by CMS, manufacturers would be required to respond to a so-called “price verification survey” by providing not only clinical and utilization information about the drug, but also costs of production, distribution, research, and marketing; revenue and profit; and ex-U.S.

Manufacturing 59

Manufacturing Vaccination Government Diagnosis 59

GeriPal

APRIL 20, 2023

We would drill down on the tenth differential diagnosis of medium vessel vasculitis, and then we would discharge them back out to the streets. Why was I spending all this time figuring out the detailed differential diagnosis of these obscure diseases when we weren’t actually attending to what people really needed?

Mental Health 124

Mental Health IT Community Individual 124

GeriPal

DECEMBER 21, 2023

But what happened when we finally… When he did get the diagnosis, it all fell into place. So IU, we have been able to convert our paper, Chris Callahan paper that was published in 2006, the first clinical trial that was positive. So what that means is I take care of you just in my clinic, just in my hospital.

Patient-Centered 126

Patient-Centered IT Families Family 126

GeriPal

SEPTEMBER 14, 2023

That’s focused on older adults who are too frail to get into clinic. In that clinical experience, we saw a lot of older adults who would develop acute illness, often exacerbations of their chronic conditions. We relied on our clinical experience as geriatricians, that home-based primary care experience. Bruce: Sure.

Hospital 115

Hospital Patient-Centered Supply Chain IT 115

PEMBlog

DECEMBER 4, 2024

We will review the clinical presentation, diagnostic strategies, management protocols, infection control practices, and vaccination updates. Learning Objectives Understand the clinical progression of pertussis through its three distinct stages and identify key symptoms, including age-specific presentations in infants and older children.

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IT Vaccination Diagnosis Complication 52