FDA Law

DECEMBER 11, 2023

This is based on FDA’s reported 2018 review of the CLIA database. [2] This is 50% greater than the 2018 numbers relied upon by FDA in its estimates. [3] 11] In fact, in Fiscal Years 2018 – 2022, fewer than 100 510(k)s went through the Third-Party Review Program annually. [12] of 510(k) decisions, respectively. [13]

IT 69

IT Medical Patient-Centered Provider 69

FDA Law

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law

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. These lab tests are performed for physicians, substance abuse treatment centers and other types of organizations.

Lab Testing 40

Lab Testing Individual Referral Patient-Centered 40

Physician's Weekly

JUNE 17, 2025

BKPyV-DNAemia is common after kidney transplant but rarely leads to graft loss or death, likely due to improved screening and management practices. The study investigated the prevalence of BKPyV-DNAemia in 522 adult patients who received a kidney transplant between 2010 and 2018. Odds ratios (ORs) were 2.53

Screening 59

Screening Patient-Centered Management Patients 59

GeriPal

SEPTEMBER 7, 2023

Does it improve outcomes that patients, caregivers, and clinicians care about? hint: 80% can be done in advance by patients or caregivers) Why is it that some oncologists are resistant to conducting a geriatric assessment, yet have no problem ordering tests that cost thousands of dollars? Welcome back, William. William: Thanks so much.

Patient-Centered 130

Patient-Centered IT Patients Clinic 130

GeriPal

OCTOBER 10, 2024

And they begin on today’s podcast with one clinical ask: everyone should be a generalist and a specialist. They are looking to build on both their research and clinical programs and are interviewing candidates for the Associate Chief of Research and for full-time physician faculty to join them in the inpatient and outpatient setting.

Screening 121

Screening IT Families Family 121

GeriPal

OCTOBER 24, 2024

If you believe the evidence for efficacy to manage symptoms like neuropathic pain, how do you even start to think about recommending these products to patients? And then I met a patient in clinic once who asked me a lot of really intelligent questions about medical cannabis, what it does. They just kept at it.

Medical 100

Medical IT Patient-Centered Healthcare 100

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. Clinicians are able to shape the environment in which people give birth by caring for the earth and their patients.

Community 52

Community Patient-Centered Families Family 52

GeriPal

MARCH 2, 2023

The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. There are a lot of reasons that may explain the massive increase in use of these drugs.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

GeriPal

FEBRUARY 6, 2025

On todays podcast, weve invited Nathaniel Chin back to the GeriPal podcast to talk about what primary care needs to manage this new world of Alzheimers disease effectively. He is associate professor at the University of Wisconsin and medical director of their Alzheimer’s Disease Research Center. Nate 00:25 Thanks for having me.

Primary Care 97

Primary Care Diagnosis Screening IT 97

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”.

Patient-Centered 98

Patient-Centered IT Clinic Patients 98

GeriPal

FEBRUARY 15, 2024

The insight started when Carmen, an orthopedic surgeon-researcher, and Katie, a physical therapist- researcher participated in ride-alongs with EMS providers to patient’s homes. Going into patient’s homes was eye opening. It was eyeopening to see patients in their own home. And so that really triggered my interest.

Community 116

Community Transportation IT PCP 116

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. Guidelines for field triage of injured patients: recommendations of the National Expert Panel on Field Triage, 2011. Harding, M., Pediatrics.

Patient-Centered 52

Patient-Centered Patients IT Hospital 52

GeriPal

MARCH 3, 2022

This idea that for critically ill patients in the ICU, geriatric conditions like disability, frailty, multimorbidity, and dementia should be viewed through a wider lens of what patients are like before and after the ICU event was transformative for our two guests today. I want to say like 2017, 2018, something like that.

Patient-Centered 96

Patient-Centered Patients IT Illness 96

GeriPal

APRIL 24, 2025

We and our guests have noticed that in our clinical practices, patients and caregivers seem to be asking for such treatments more frequently. If its potentially unsafe, but has robust evidence, well thats most of the treatments we offer seriously ill patients! Think chemotherapy to imminently dying patients, or CPR.

Patient-Centered 79

Patient-Centered IT Patients Illness 79

GeriPal

MARCH 27, 2025

Summary Transcript CME Summary A pragmatic trial evaluates the effectiveness of a treatment or intervention in real-world clinical practice. Only 5% of intervention patients received the facilitator-led component of the intervention (there were other components, facilitator-led was the most engaged component). Is that right?

Primary Care 80

Primary Care IT Clinic Illness 80

GeriPal

APRIL 21, 2022

Poetry puts us in our patient’s shoes. Poetry holds us in that liminal space so many of our patients are in. Look also for a forthcoming article by Mike and Redwing in Journal of Pain and Symptom Management on poetry as a healing modality, to be published mid May (will add link when out). Welcome to the GeriPal podcast, Redwing.

Patient-Centered 93

Patient-Centered IT Community Illness 93

GeriPal

FEBRUARY 24, 2022

Should we focus on something else, both from a clinical and a research perspective? We see our patients and our families throughout the illness trajectory into the hospital. And maybe we should have more patient-centered conversations. Like, should we be doing advance care planning? What’s the evidence behind it?

Illness 98

Illness Patient-Centered IT Patients 98

Physician's Weekly

JUNE 25, 2025

Insurers also pledged to use clear language when communicating with patients and promised that medical professionals would review coverage denials. “The pledge is not a mandate,” Mehmet Oz, administrator of the Centers for Medicare & Medicaid Services, said during a news conference.

Insurance 52

Insurance Patient-Centered Patients Government 52

PEMBlog

MAY 9, 2024

2018 Nov;142(5):e20181009. Epub 2018 Oct 8. Both the motor movements and characteristics of the seizure, as well as the duration, are really hard to assess in a patient’s home. So what’s the evaluation and management for simple febrile seizures? How do we evaluate and manage them? Pediatrics.

Illness 59

Illness Vaccination Families Family 59

FDA Law

SEPTEMBER 13, 2021

In 2018, Trump’s Department of Health and Human Services (HHS) released its Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs , but the edifice envisioned by the Blueprint largely failed to materialize. Controlling Medicare Part D Patient Out-of-Pocket Costs and Total Drug Costs. Controlling Drug Price Increases.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98