FDA Law Blog

NOVEMBER 7, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. One less utilized method (and for good reason) to gain more certitude is the 513(g) Request for Information. Gibbs — In most instances, it is clear if a product will be considered a “device” under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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Provider IT Consulting Utilities 69

FDA Law Blog

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 Blog

JULY 4, 2023

The CARES Act also provides for an administrative hearing process that may be utilized under certain conditions following the formal dispute resolution process. The draft Monograph FDR Guidance clarifies that FDR is appropriate only when there is a scientific and/or medical dispute related to a final order.

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Utilities Provider Individual IT 52

PEMBlog

SEPTEMBER 13, 2023

Selecting the appropriate medications, if necessary, is of paramount importance. The lack of utility of laboratory testing in children with an unprovoked generalized seizure, or a simple febrile seizure is supported by several observational studies. This includes scarring abnormalities, bleeds, and tumors. Glucose We all need it.

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Patients Screening Illness Physicals 52

PEMBlog

MAY 15, 2023

Our role as providers is to identify the patients who have a life-threatening etiology to their syncope. Your history and medication reconciliation will assist in determining acquired vs congenital variants. Acquired long QT can be caused by electrolyte disorders, eating disorders and/or medications. 2017): 189-198.

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Utilities Screening Physicals Family 97

The Clinical Problem Solvers

FEBRUARY 8, 2023

Pearls: In 2020, American Indian and Alaska Native (Indigenous) communities experienced the highest drug overdose mortality rate of any racial or ethnic group, also surpassing rates among the non-Hispanic white population. They can use their training and privilege to advocate for meaningful policy reform.

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GeriPal

JANUARY 25, 2024

Summary Transcript Summary In a JAMA 2020 systematic review of palliative care for non-cancer serious illness, Kieran Quinn found many positives, as we discussed on our podcast and in our editorial. With their regular providers? The article we discuss today, also published in JAMA , addresses these two gaps. David: Thank you.

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FDA Law Blog

JUNE 7, 2021

It is noteworthy that this sentence that no clinical benefit has been established was deemed by FDA as unnecessary for Aduhelm to provide additional context beyond that the approval is based on reduction in amyloid beta plaques. be “reasonably likely to predict” ultimate clinical benefit). Yesterday’s approval of Aduhelm helped answer that.

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Clinic IT Private Practice Utilities 98

GeriPal

OCTOBER 26, 2023

Within hours of recording this podcast, I joined a family meeting of an older patient who had multiple medical problems including cancer, and a slow but inexorable decline in function, weight, and cognition. We provide critical education. We provide critical conversations with colleagues and families to coordinate transition planning.”

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Patient-Centered Hospital Patients IT 132

GeriPal

OCTOBER 19, 2023

And we have Scott Halpern, who is Professor of Medical Ethics and Health Policy and Director of the Palliative and Advanced Illness Research Center or Payer Center at the University of Pennsylvania. So now it’s just POLST, the word POLST, Portable Medical Orders. Hey, it’s National POLST Collaborative now. Good to know.

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Patient-Centered IT Patients Illness 126

FDA Law Blog

JULY 9, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & Sarah Wicks & Deborah L. DAP Content In developing DAPs, the Draft Guidance recommends that sponsors consider whether certain demographic groups may have a different response to a medical product regarding either effectiveness or safety. 360j(g)(9)(A)).

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Clinic Provider Individual IT 59

GeriPal

JANUARY 20, 2023

You were on a National Academy of Sciences committee started in 2020? To me, I think the Greenhouse folks have proven that you can provide quality care in a home-like environment cost effectively if it’s done right. Eric: All right, let’s jump into this topic. Improving nursing home quality. Jasmine: Yes. Is that right?

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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. From 2019 to 2020, the rate of firearm related deaths among children increased by 30%. In our current environment, it can feel overwhelming as a healthcare provider to discuss firearms. Children’s Defense Fund. 2022, March 18).

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Family Families Mental Health Healthcare 52

GeriPal

APRIL 10, 2025

Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it. We weren’t randomizing providers or patients. Do they have documents in the record like medical orders for life sustaining treatment or a healthcare proxy?

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Patient-Centered IT Hospital Patients 77

FDA Law Blog

AUGUST 21, 2023

Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. Recall that the funds provided under the Prescription Drug User Fee Acts (PDUFA) are not available to support the agency’s efforts related to monograph drugs.)

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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.

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Manufacturing Vaccination Government Diagnosis 59

GeriPal

FEBRUARY 13, 2025

Like, would you include the doctors that I work with, healthcare providers where I live in Marin? And resource utilization was very low in all the groups. But again, hindsight’s 2020 probably wasn’t the best measure to look the other one we tested in an exploratory way was feeling heard and understood.

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Consulting Community Patient-Centered Families 63

GeriPal

JULY 6, 2023

It was designed to really balance what Medicaid at the time was to provide nursing homes and Medicare is obviously health insurance. The long-term care is being actually provided in the community at a much higher rate than what the formal system provides. But, what you need is a community-based game there. They deal with that.

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Community Nurse Practitioner Provider IT 89

FDA Law Blog

AUGUST 14, 2022

The negotiations will result in a Maximum Fair Price (“MFP”) that the manufacturer must make available to providers furnishing the drug under Medicare Part B or pharmacies dispensing the drug under Part D. Manufacturers receive no benefits in exchange for the inflation rebates.

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Manufacturing Government Vaccination Utilities 98

GeriPal

DECEMBER 21, 2023

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.”

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Patient-Centered IT Families Family 125

FDA Law Blog

NOVEMBER 8, 2023

The rule established a new category of OTC hearing aids for individuals with mild to moderate hearing loss, allowing them to purchase hearing aids directly from stores or online retailers without the need for a medical examination, prescription, or fitting adjustment by an audiologist. However, FDA missed that deadline.

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