Physician's Weekly

JUNE 25, 2025

It’s “going to streamline it in some incremental ways only,” Dr. Adam Gaffney , a critical care doctor and assistant professor at Harvard Medical School, told NBC News. Medical professionals will be required to review all denials (though insurers say they already do this).

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My Green Doctor

APRIL 4, 2025

New Research: Teaching Patients about Climate Resilience Newly published original research co-authored by My Green Doctor’s Dr. Todd Sack concludes that, “ the medical office waiting room appears to be an accepted, time-efficient, and effective site to communicate knowledge on climate change and health. ” Contact us today! of total U.S.

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PEMBlog

OCTOBER 31, 2024

However, this large study shows that probiotics do not significantly shorten illness duration, improve symptoms, or reduce the need for additional medical visits. 2018 Nov 22;379(21):2002-2014. N Engl J Med 2018; 379:2015-2026. By using the latest research, parents can focus on more effective treatments like hydration.

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Aspiring Minority Doctor

MARCH 14, 2022

For those who aren’t aware, today is Match Day where thousands of 4th year medical students and graduates find out if they have secured a residency position. For many, this is a joyous day filled with celebrations and sighs of relief, but for the unmatched, this can be one of the most depressing experiences of an entire medical school career.

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Medical Xpress

FEBRUARY 28, 2023

of high-risk hypercholesterolemia patients never achieve the low-density lipoprotein-cholesterol (LDL-C) thresholds recommended in the 2018 American College of Cardiology/American Heart Association Guideline on the Management of Blood Cholesterol.

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Insurance Management Family Families 74

FDA Law Blog

JULY 17, 2024

An Opportunity to Leverage the Newly Created Rare Disease Advisory Committee across CDER and CBER In Frank and James’ 2018 proposal there was also a recommendation for the formation of a Rare Disease Advisory Committee, which would allow FDA access to experts in the science of small trials and other aspects of rare disease research.

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FDA Law Blog

DECEMBER 2, 2024

We noted that the draft guidance’s discussion on determining a device’s contact duration raised concern as it contradicted ISO 10993-1:2018, Biological evaluation of medical devices —Part 1: Evaluation and testing within a risk management process. KP Medical Device Consulting LLC

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FDA Law Blog

FEBRUARY 18, 2025

The answers below are based on my experience as a reviewer and compliance officer at FDA during the 5-week 2018/2019 government shutdown. Examples: A manager has three approval letters to review and a binder of lot release papers. Once those reviews are complete, the manager is furloughed for the rest of the day and goes home.

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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. Discuss options like oral medications, intranasal routes, or the presence of trusted caregivers during procedures. 2018 May/Jun;79(3):17r11506. Pediatrics. 2019-1895L.

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Family Families Patient-Centered Physicals 77

Physician's Weekly

JUNE 25, 2025

Supporters said it was meant to close a legal loophole created in 2018 when a federal law allowed states to regulate hemp, a plant that can be processed to create THC. Recreational use is banned, and the medical marijuana program is limited. Texas has some of the strictest marijuana laws in the country.

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The Clinical Problem Solvers

DECEMBER 16, 2020

Our guests explain how we can incorporate race-conscious medicine in clinical settings, medical education, and biomedical/epidemiological research to responsibly recognize and address the harms of racial inequality. These factors include a high-protein diet, muscle mass, creatinine generation, and certain medications. link] Tsai J.

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FDA Law Blog

NOVEMBER 20, 2024

Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. of ISO 10993-1:2018, but is extremely burdensome and not referenced in the related ISO 10993-18.

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FDA Law Blog

MARCH 6, 2022

Part 820, with a newly named Quality Management System Regulation (QMSR). The QMSR omits many of the specific QSR requirements that currently appear in the regulations, and instead incorporates by reference an international standard for medical device quality management systems.

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BMJ

JULY 17, 2020

7 Moreover, medical professionals, health practitioners, and relevant academic institutions should proactively disseminate creditable news and information during such health outbreaks through mainstream social media channels. Shaanxi, Xi’an, China: Shaanxi Normal University; 2018. Scholars such as Wen et al. Doctorate [dissertation].

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FDA Law Blog

DECEMBER 16, 2024

Lenz, Principal Medical Device Regulation Expert FDA recently released 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review which finalizes the draft guidance of the same title issued in December 2023. The Agency has reportedly been trying to improve the program, as we discussed in 2018 and 2020.

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GeriPal

JUNE 8, 2023

When I’m on palliative care consults and attending in our hospice unit we have to counsel patients about deprescribing and de-intensifying diabetes medications. Our last podcast was with Laura Petrillo in 2018 – 5 years ago seems ancient history – though many of the points still apply today (e.g. How high is too high?

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Diabetes Management Patient-Centered Family 73

FDA Law Blog

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]

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FDA Law Blog

SEPTEMBER 26, 2022

Lenz, Principal Medical Device Regulation Expert & Holly N. requires generally that manufacturing of a combination product (CP) must comply with the applicable current Good Manufacturing Practice regulations (cGMPs) for all of its components ( i.e., a drug/device CP must follow the cGMPs for drugs as well as those for medical devices).

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PEMBlog

APRIL 20, 2023

Cristina Tarango, director of the Hemophilia Treatment Center at Cincinnati Children’s and Lisa Littner, Project Manager at Cincinnati Children’s who helped me research and write this post. Emicizumab (Hemlibra) was approved in 2018 for routine bleeding prophylaxis in hemophilia A with or without inhibitors.

Individual 52

Individual Patient-Centered Patients IT 52

FDA Law Blog

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. EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s blog here. 18 U.S.C. § 18 U.S.C. § 220(e)(2).

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GeriPal

MAY 19, 2022

I think part of it’s the math, but I think what really happened is, I think the story here is that in 2018, MD Anderson published this really landmark study by Dr. Reddy and her colleagues about going from IV Dilaudid to other to oral Dilaudid, oral hydromorphone, I should say, oral morphine and oral oxycodone. Is that right?

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FDA Law Blog

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. EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s blog here. 18 U.S.C. § 18 U.S.C. § 220(e)(2).

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Lab Testing Referral Individual Patient-Centered 40

Physician's Weekly

JUNE 15, 2025

This review compares guidelines from the American Society of Clinical Oncology (ASCO), the European School of Oncology-European Society of Medical Oncology (ESO-ESMO), the National Comprehensive Cancer Network (NCCN), and the Society of Obstetricians and Gynaecologists of Canada (SOGC) for managing sexual health symptoms.

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FDA Law Blog

SEPTEMBER 20, 2021

FDA will discuss the goals letter and field public comments, on September 28, 2021 (announcement here ), as well as a separate workshop on meetings management practices, which is to be held by July 30, 2024. Finally, FDA will hold a public workshop on meeting management.

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Patient-Centered Manufacturing Clinic Provider 52

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? laughter] Alex 01:39 Material here for songs related to medical marijuana or marijuana in general. Eloise 00:59 Thank you so much. Eric 01:34 Yeah. David 04:31 Yes.

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Physician's Weekly

JUNE 19, 2025

Pregnant with her second child, she schleps a backpack instead of a traditional black bag to carry a laptop and essential medical supplies — stethoscope, blood pressure cuff, and pulse oximeter. “It’s also often the family member or the person helping to manage them.”

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FDA Law Blog

OCTOBER 17, 2023

Compared to the previous version, the new guidance document highlights that the Breakthrough Devices Program may also be applicable to certain devices that benefit populations impacted by health and/or healthcare disparities and to certain non-addictive medical products to treat pain or addiction. By Philip Won & Lisa M.

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Medical Diagnosis Healthcare Clinic 53

Physician's Weekly

JUNE 22, 2025

These outcomes were adjusted for variables including age, race, ethnicity, income, health insurance, educational status, and coexisting medical conditions. These included how well physicians demonstrated respect, listened to individuals, explained information, and spent enough time with them. vs 3.32, P = 0.023).

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Individual Insurance Education Medical 59

GeriPal

MARCH 2, 2023

2022 Perioperative Gabapentin Use in Older AdultsRevisiting Multimodal Pain Management JAMA IM. JAMA Surgery 2018 Gabapentin and mood stabilizers in the Nursing Home Setting: Antiepileptic prescribing to persons living with dementia residing in nursing homes: A tale of two indications. It’s not a controlled substance medication.

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The Clinical Problem Solvers

NOVEMBER 6, 2023

Harrison Time Stamps 00:00 Opening 00:45 Introductions 03:07 Guest Introduction 1 04:46 Guest Introduction 2 08:15 On the Intersection of Black, Fat, and Trans Communities and the Medical-Industrial Complex 13:35 History and the Racial Underpinnings of Food Shaming in the U.S. Episode Takeaways Origin Stories – For Dr. Psyche A. Taylor, S.

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Community Manufacturing Patients Medical 52

FDA Law Blog

MAY 16, 2024

UMHS agreed to resolve the allegations in August 2018 for $4,300,000 and compliance with a three-year Memorandum of Agreement (“MOA”). Press Release – DEA began investigating Cheshire Medical Center (“CMC”) in New Hampshire in February 2022 after it reported that a nurse stole twenty-three fentanyl intravenous solutions (“IV”) bags.

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Hospital Patient-Centered Medical Provider 59

GeriPal

OCTOBER 10, 2024

Alex 01:23 And we’re delighted to welcome DorAnne Donesky, who is a palliative care nurse practitioner at Queen of the Valley Medical center in Napa and professor emeritus at the UCSF School of Nursing. DorAnne 30:25 I also wanna make a shout out for pain and symptom management with social work and chaplains. I don’t know.

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GeriPal

APRIL 3, 2025

We covered: The first parody song I wrote, for AGS 2018 in Orlando , about this article by Nancy Schoenborn on how to discuss stopping cancer screening. Alex joined in 2018. This was 2018 in AGS Orlando, and they did a song about when to stop screening for cancer for colon cancer. Alex 05:15 Oh, really? And so we did this song.

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IT Hospital Screening Patients 64

GeriPal

JUNE 22, 2023

Summary Transcript Summary In the early 1990’s, California Medical Facility (CMF) created one of the nation’s first licensed hospice units inside a prison. Alex: We are in the California Medical Facility and we will ask our guest about that. I’ve known Michele a long time, since the Joint Medical Program. Michele: Yep.

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GeriPal

FEBRUARY 15, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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GeriPal

JULY 21, 2022

Eric: For those of you don’t know, Emmy was on our podcast back in 2018 … man, pre-COVID times. Emmy: But we know that physiologic changes with aging, like decreasing night vision and so forth, as well as medications, as well as medical conditions, can all affect whether you can drive. Weren’t those the days?

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Family Families IT Diagnosis 102

GeriPal

MAY 12, 2022

In this podcast, we cover a great deal of ground, including: Early challenges Dr. Raj faced in pain management: access to opioids, corruption, a system that doesn’t see addressing suffering as a priority. Raj: It was indeed very, very gradual, and the seeds were sown when I was a medical student. Was it that thunderclap moment?

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