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the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Interpretation of Statutory Criteria Under the Final Guidance. Medical information about a patient.

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PEMBlog

APRIL 22, 2025

Manage Wait Times with Intentionality Long, unstructured waits are hard for all kidsbut especially for autistic children who rely on routine and predictability. Work with your hospitals care coordination team to create pathways for kids with recurrent ED visits. 2019-1895L. The Journal of Clinical Psychiatry. Pediatrics.

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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.

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PEMBlog

SEPTEMBER 27, 2023

The Choosing Wisely Pediatric Emergency Medicine Recommendations The Choosing Wisely Campaign Toolkit Expert Contributors Olivia Ostrow, MD Hospital for Sick Children Toronto, Ontario, Canada olivia.ostrow@sickkids.ca Comprehensive respiratory viral panels (i.e., Reasons to not order a comprehensive respiratory viral panel (i.e.,

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The Clinical Problem Solvers

APRIL 3, 2023

Michael’s Hospital in Unity Health Toronto, and Dr. Alika Lafontaine, the current President of the Canadian Medical Association. Cambridge: Cambridge University Press; 2019:185-194. Racialised people in clinical guideline panels. Racialised people in clinical guideline panels. Healthc Manage Forum. Can J Surg.

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PEMBlog

SEPTEMBER 24, 2024

Pulmonology and surgery were consulted during his hospital stay, and he has since had a left lower lobectomy after healing from his pneumonia. Most patients are afebrile by the third day of treatment and clinically improved within two weeks. 2019 Apr 1;48(4):e169-e174. Management of Congenital Lung Malformations.

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FDA Law Blog

JANUARY 6, 2022

In general, EKRA prohibits, knowingly and willfully, soliciting, receiving, paying or offering kickbacks in exchange for referring to, inducing a referral to, or using the services of a recovery home, clinical treatment facility, or laboratory. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § EKRA Issue.

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FDA Law Blog

JANUARY 6, 2022

In general, EKRA prohibits, knowingly and willfully, soliciting, receiving, paying or offering kickbacks in exchange for referring to, inducing a referral to, or using the services of a recovery home, clinical treatment facility, or laboratory. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § EKRA Issue.

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Common Sense Family Doctor

DECEMBER 4, 2024

A recent editorial in the Journal of the American Heart Association discussed a “paradigm shift” in management of severe aortic stenosis: 69% of Medicare fee-for-service beneficiaries who underwent aortic valve replacement from 2012-2019 had TAVI, with the percentage undergoing SAVR falling from 75% in 2012 to just 10% in 2019.

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GeriPal

FEBRUARY 27, 2025

Substance use disorder is one of those complex issues in which clinical practice is changing rapidly. Sach Kale set up an outpatient clinic focused on substance use disorder for patients with cancer. Do you need to be an addiction medicine trained physician to start such a clinic (no: Sach is not). What do they do?

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The Clinical Problem Solvers

MAY 30, 2022

Kozhimannil—the Distinguished McKnight University Professor in the Division of Health Policy and Management at the University of Minnesota and Director of the Rural Health Research Center. Dr. Kozhimannil discusses her work on rural maternity care and the lack of hospital-based obstetric services. Published January 16, 2019.

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GeriPal

MAY 18, 2023

Alex: And we’re delighted to welcome Todd Semla, who is a clinical pharmacist and associate professor at the Feinberg School of Medicine at Northwestern University. Mike: 2019. Eric: 2019. So in those clinical situations, you should consider avoiding that drug. You have to take that into consideration clinically.

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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. James 00:32 Good afternoon.

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Medical Xpress

JUNE 8, 2025

The commonest strategy to manage acute pain in preterm babies is to give them sucrose , a sugar solution. Long-term effects of pain in early life We collected data on the number of procedures, clinical exposures and sucrose doses from three NICUs across Canada. One of these sites does not use sucrose for acute pain management.

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IT Management Vaccination Medical 53

GeriPal

MARCH 2, 2023

2022 Perioperative Gabapentin Use in Older AdultsRevisiting Multimodal Pain Management JAMA IM. AFP 2019 Gabapentin for chronic neuropathic pain in adults. Eric: And we have Tasce Bongiovanni, who is an acute care trauma surgeon at UCSF and the San Francisco General Hospital. I understand that it can be a hard place clinically.

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GeriPal

APRIL 13, 2023

Are there meaningful ways of assessing loneliness and social isolation in clinical settings and connecting patients with interventions? The Listening “EAR” approach that simplifies assessment of loneliness and social isolation in clinical settings, and other practical pointers.

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PEMBlog

JUNE 5, 2024

It was inspired by a hot-off-the-presses publication from the Pediatric Emergency Care Applied Research Network (PECARN) focused on clinical decision rules for cervical spine imaging in children. 2019 Jul;144(1):e20183221. Let’s go ahead and pivot to initial management. Here is the aforementioned PECARN paper: Leonard, J.

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GeriPal

AUGUST 25, 2022

And yet, we know little about the clinical experience of people with dementia in hospice. For-profit hospices having much higher rates of their patients visiting the emergency department and being hospitalized, in addition to disenrollment. As a nurse case manager in hospice, half of my patients had dementia.

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GeriPal

MARCH 24, 2023

Full disclosure, I talked with Ava Kofman a bunch while she was preparing that article, and I thought based on my professional experience working in hospice, things that I had seen, that she raised a lot of issues that I had personally encountered in my clinical experience. Management, it’s hard. Who sees you? How is that done?

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FDA Law Blog

SEPTEMBER 30, 2024

CMS did not finalize the price verification survey, which would have required manufacturers of 10 costly drugs selected annually to provide clinical information as well as information on production, distribution, research, and marketing costs, revenue and profit, and ex-U.S. pricing, among other things. See 42 U.S.C. 1396r-8(b)(3)(C)(iii).

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PEMBlog

APRIL 26, 2023

I’m Dr. Carney and I am a pediatric resident at Cincinnati Children’s Hospital Medical Center. Today, we are going to discuss firearm safety and ways to screen for it in both the ED and clinic settings. From 2019 to 2020, the rate of firearm related deaths among children increased by 30%. Thank you for hosting us, Brad!

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PEMBlog

APRIL 4, 2025

Immunization status and the management of febrile children in the pediatric emergency department: what are we doing? Unfortunately, timely clinical question, what do we do with the UN or under vaccinated child who presents to the emergency department with fever? Pediatr Emerg Care. 2023;39(1):1-5. doi:10.1097/PEC.0000000000002864

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GeriPal

APRIL 17, 2025

Eric 10:04 And how many Major League managers are. So that Jackie Robinson had hoped to become a manager after he left baseball. And in his hall of Fame speech, he called for the day where there would be black managers in baseball. So basically the two best managers in baseball. I took my kids in 2019, 2020.

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The Clinical Problem Solvers

DECEMBER 2, 2020

[link] In this episode of Clinical Problem Solvers: Anti-Racism in Medicine, we sit down with Ed Yong, an award-winning journalist and science writer with The Atlantic , to discuss the structural inequities amplified by COVID-19 as well as the social concerns associated with the impending/present second wave of the pandemic. The Atlantic.

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FDA Law Blog

SEPTEMBER 13, 2021

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.

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