PEMBlog

SEPTEMBER 6, 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. 2015;34(5):812-818 Chun TH.

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Lab Testing Medical Patients Mental Health 52

FDA Law Blog

APRIL 23, 2023

This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources. The Draft Guidance recommends that, where possible, the outcome should be assessed by individuals blinded to treatment status, which may require re-adjudication of externally controlled data.

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FDA Law Blog

JUNE 27, 2024

to promote therapeutic appropriateness by identifying: (a) Over-utilization or under-utilization; (b) Therapeutic duplication; (c) Drug-disease contraindications; (d) Drug-drug interactions; (e) Incorrect drug dosage or duration of drug treatment; (f) Drug-allergy interactions; [and] (g) Clinical abuse/misuse.” By Larry K.

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Insurance Patients Utilities Chronic Condition 52

FDA Law Blog

SEPTEMBER 20, 2021

Some of these will be subjects of more detailed posts in the future and readers should keep an eye on the blog for additional coverage. The sponsor then gets the review ball rolling by submitting all of the efficacy supplement minus the final clinical study reports and clinical summaries.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law Blog

JUNE 16, 2023

The statute confuses the issue by providing that “every individual transaction in violation of [the excessive price increase prohibition] is considered a separate violation,” making it unclear whether this is a per-day or per-transaction penalty, and, if the latter, what the transaction is.

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Manufacturing Provider Consulting IT 45

FDA Law Blog

OCTOBER 16, 2024

Left ventricular ejection fraction (LVEF) is a variable measure, so use clinical judgment in deciding whom to treat.” The skinny label—whether utilizing omission or labeling modification—can continue to exist, allowing generic manufacturers to come to market earlier for non-protected uses of RLDs.

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Manufacturing Patients IT Hospital 98

GeriPal

APRIL 14, 2022

So I have thought about this for months, maybe years since your 2016, cycle blog, but we have picked Under Pressure by David Bowie and Queen. This is both a research and a clinical interest of yours. They don’t have an addiction clinic. Eric: And why Under Pressure. I’m going to start off with Katie. Right, Katie?

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Illness Patient-Centered IT Patients 102

FDA Law Blog

JULY 9, 2024

Livornese — The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022, added a requirement that sponsors submit Diversity Action Plans (“DAPs”) for certain clinical studies involving drugs, biological products, or devices (codified at 21 U.S.C. § 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)). intended use population.

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Clinic Provider Individual IT 59

PEMBlog

MARCH 27, 2024

She did her MD/PhD at Columbia University, where she investigated the diagnostic utility of exome sequencing for kidney disease. Meaning that an individual must inherit two copies of the mutation, so one from each of his or her parents, to be affected. And not all IEMs are included on NBS, NBS can miss individuals with IEMs.

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Consulting Individual Families Family 59

FDA Law Blog

FEBRUARY 22, 2022

Additionally, the NIH assists with all the analytical and clinical testing, using protocols already vetted with FDA. This testing is done by testing labs and clinical research organizations (CROs). To our knowledge, five clinical studies conducted by NIH have failed to hit 80% sensitivity.

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Manufacturing Screening Provider Clinic 52

GeriPal

DECEMBER 19, 2024

So we’re going to be talking about palliative care for individuals with mental illness. Eric 07:03 Yeah, it’s hard because you can also think about it, let’s say, because we see palliative heart failure clinics. Depending on your geography, who you are as an individual, the ethical parameter you’re considering.

Illness 101

Illness Mental Health IT Patient-Centered 101

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

SEPTEMBER 19, 2024

So, basically, with a stepped care model, the goal is to tailor care delivery to the patient’s needs while at the same time utilizing less clinician resources. Eric 07:31 A clinical perspective, why is it important to test this stepped care model versus implementing more? This is Eric Widera. Jennifer 04:25 I can take that on.

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Patient-Centered IT Patients Hospital 119

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. In some measurable ways, the rule has been a success.

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Utilities IT Engineering Appointment 64

FDA Law Blog

SEPTEMBER 13, 2021

Medicare negotiation authority; encourage biosimilars and generic drug utilization). Currently, individual Medicare Part D plan sponsors negotiate rebates but the government is explicitly prohibited from interfering in those negotiations. Drug Price Negotiation to Benefit Medicare and Commercial Plans.

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Manufacturing Supply Chain Patient-Centered Utilities 98