FDA Law Blog

MAY 8, 2023

The discussion paper described a PCCP as including (1) the types of anticipated modifications (SaMD Pre-Specifications or SPS) based on the retraining and model update strategy and (2) the associated methodology (Algorithm Change Protocol or ACP) being used to implement those changes in a controlled manner to manage patient risks.

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Manufacturing Provider Medical IT 98

FDA Law Blog

MAY 4, 2023

Section 3606(a) of the Food and Drug Omnibus Reform Act (FDORA) directed FDA to “issue or revise draft guidance that includes recommendations to clarify and advance the use of decentralized clinical studies to support the development of drugs and devices,” not later than December 29, 2023. DHTs include monitoring instruments (e.g.,

Clinic 59

Clinic Telehealth Provider Electronics 59

Medical Xpress

JUNE 16, 2025

Ibogaine shows potential for promoting neuroplasticity and aiding recovery, though it carries cardiac risks that require careful management. However, we do not guarantee individual replies due to the high volume of messages. The initiative aims to attract additional private investment and facilitate FDA approval.

Mental Health 52

Mental Health IT Medical Specialization 52

PEMBlog

MARCH 27, 2024

This episode will help you better prepare for and manage children with inborn errors of metabolism in the Emergency Department. My special guest podcaster, Emily Groopman, is an actual Pediatric Geneticist in training and we hope that you will find this episode useful. Updated 2023 Jul 17]. Inborn Errors of Metabolism.

Consulting 59

Consulting Individual Family Families 59

FDA Law Blog

APRIL 8, 2024

In its report, Drug Shortages: Root Causes and Potential Solutions, FDA explains that the equipment needed to produce sterile injectables is highly specialized and expensive, meaning that in a shortage situation, production capacity cannot be substantially increased without taking the time and expense of procuring and qualifying new equipment.

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

PEMBlog

JANUARY 16, 2025

Learn how to recognize and manage cases in the emergency department, ask the right questions to uncover inhalant use, and provide critical resources for prevention and support. Formulate effective strategies for identifying, managing, and preventing inhalant misuse in pediatric patients. Clin Toxicol (Phila) 2023; 61:453.

Complication 52

Complication Patient-Centered Management Patients 52

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 01:34 Yeah, right on.

Illness 109

Illness IT Patient-Centered Patients 109

GeriPal

MARCH 24, 2023

JAMA IM 2023 A shout-out to my NPR episode on 1A titled the “State of Hospice Care” DISCLAIMER While we filmed in Montreal during the Annual Assembly, all opinions expressed in this podcast are independent of AAHPM and HPNA, or the Annual Assembly. How many patients is my hospice nurse case manager responsible for on any given day?

IT 115

IT Provider Patients Family 115

GeriPal

FEBRUARY 8, 2024

Hospital Chaplains, Spirituality, and Pain Management: A Qualitative Study. Pain Manag Nurs. 2023 Dec 20:S1524-9042(23)00202-3. Naomi: Well, I have a special place of not being a doctor within this great group of people. doi: 10.1016/j.pmn.2023.11.004. 2023.11.004. Epub ahead of print. PMID: 38129210. Kleinman, A.

IT 137

IT Family Families Physicals 137

GeriPal

APRIL 6, 2023

Alex Practice-PC Program Information: UCSF’s Practice-PC program is now accepting applications for the 2023-2024 year. We welcome all professions, including but not limited to physicians, chaplains, social workers, nurses, nurse practitioners, case managers, administrators, and pharmacists. This is Eric Widera. Lexy: Yeah.

IT 99

IT Patient-Centered Family Families 99

GeriPal

APRIL 20, 2023

What are the structural factors and individual factors that contribute to homelessness? Alex: But the longer title’s Ethno-Geriatrics and Special Populations. ” On that grand rounds, you differentiated structural factors from … I forget what the word was, individual- Margot: Individual risk factors.

Mental Health 124

Mental Health IT Community Individual 124

GeriPal

DECEMBER 21, 2023

This model will give participating programs a per-member-per-month payment to offer care management, care coordination, and other services such as caregiver training, disease education, and respite. I didn’t know how to manage it. He created fee for service, special fee for depression. And I was terrified. Malaz: Correct.

Patient-Centered 126

Patient-Centered IT Family Families 126

GeriPal

SEPTEMBER 14, 2023

The patients that, I think, most benefited from it were those individuals who, as I said, maybe, had a pneumonia, and needed IV antibiotics, but wanted to do that… If they could get better in the comfort of their own homes, that were not interested in passing away in the hospital. We weren’t even up to Medicare Advantage.

Hospital 115

Hospital Patient-Centered Supply Chain IT 115

GeriPal

JULY 20, 2023

See the AAHPM Legislative Action Center [link] Write to the DEA, with guidance from AAHPM’s comments to the DEA March 2023. They couldn’t get a case manager to refer them in palliative care. It may have come to a care manager. Start with a story as Carly did in her Op Ed. Stories trump data. Write to your congressperson.

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Telemedicine Telehealth Patient-Centered Board-Certified 73