FDA Law Blog

APRIL 25, 2023

This provision became effective as of March 29, 2023. It will become part of the “refuse to accept” (RTA) checklist on October 1, 2023. Timeline Section 524B became effective on March 29, 2023. Special 510(k)s. Note that FDA does not conduct an RTA acceptance review for submissions submitted via eSTAR.

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PEMBlog

JUNE 7, 2023

Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. These articles will take another look at the content included in this episode. Alice Kuo and Ilene Claudius Podcast EIIC: Safe Control of the Agitated Patient Webinar Series with Dr.

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Transportation Patient-Centered Management Finance 122

Barton Associates

JUNE 19, 2025

There’s a lot that goes into running a healthcare facility , from managing patient care to ensuring adequate coverage around the clock. In these complex and ever-changing environments, staffing challenges can quickly become a critical issue, impacting both patient care quality and operational efficiency.

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Physicians Alliance of Connecticut

APRIL 12, 2025

Bureau of Labor Statistics projects that the field will grow by 15 percent from 2023 to 2033 , which is higher than the average for roles that provide support to healthcare professionals. Some medical assistants may take on more responsibility, then move into a role as a medical office manager.

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Medical Healthcare Patient-Centered Primary Care Physician 52

Physician's Weekly

JUNE 19, 2025

When Alyne Diamond fell off a horse in August 2023 and broke her back, her employer-based health plan through UnitedHealthcare covered her emergency care in Aspen, Colorado. It also covered related pain management and physical therapy after she returned home to New York City. The bills totaled more than $100,000.

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Insurance Patient-Centered Government Provider 52

FDA Law Blog

MAY 19, 2023

In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device. The Special Controls are silent on what would constitute appropriate levels of evidence necessary to satisfy this criterion. analytical, clinical and stability).

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PEMBlog

MAY 17, 2023

Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. Collaborative Care in the Identification and Management of Psychosis in Adolescents and Young Adults. These articles will take another look at the content included in this episode. Pediatrics 2021; 147.

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FDA Law Blog

JULY 17, 2024

As originally proposed, this new Committee could be convened in conjunction with the existing medical specialty area-focused advisory committees, akin to the Drug Safety and Risk Management Advisory Committee. those reviewed by the CDER Division of Rare Diseases and Medical Genetics).

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PEMBlog

OCTOBER 18, 2024

Duchenne Muscular Dystrophy (DMD) is a complex and progressive disease requiring highly specialized care, especially in emergency situations. When patients with DMD present in the Emergency Department (ED), an understanding of the nuanced aspects of their care is essential for optimal management.

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Patients Complication Management Consulting 52

The Clinical Problem Solvers

DECEMBER 16, 2020

However, the diagnostic approach used to determine changes in clinical management of renal disease (i.e. Additionally, research has shown that using symptom-prompted modifications to management, in the context of shared decision-making, can improve outcomes. dialysis, transplant) is multifactorial; it is not based on eGFR alone.

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Clinic Education Clinical Practice Patient-Centered 52

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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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.,

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PEMBlog

APRIL 20, 2023

A special thanks to Dr. 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. Epub 2023 Jan 16. Epub 2021 Oct 10. PMID: 34628693. Adv Clin Chem. 2023;113:273-315. 2022.12.001.

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Individual Patient-Centered Patients IT 52

FDA Law Blog

FEBRUARY 22, 2023

And HF‑related AI requests are especially nerve‑racking to manage, because of the ever‑present threat that the study must be repeated to adequately respond. as a de novo special control or in a guidance document for a specific device type). Comments on the draft guidance are due on or about March 8, 2023.

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Physician's Weekly

JUNE 19, 2025

“It’s also often the family member or the person helping to manage them.” The number of nurse practitioners specializing in geriatrics has more than tripled since 2010, increasing the availability of care to the current population of seniors, a recent study in JAMA Network Open found.

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PEMBlog

MAY 24, 2023

This podcast episode hosted by Brad Sobolewski ( @PEMTweets ) and co-authored by Dennis Ren ( @DennisRenMD ) is all about age-appropriate non pharmacologic management strategies for agitated children. Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. West J Emerg Med. PMC3298214.

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Management Patient-Centered Physicals Finance 54

Medical Xpress

JUNE 16, 2025

Ibogaine shows potential for promoting neuroplasticity and aiding recovery, though it carries cardiac risks that require careful management. The initiative aims to attract additional private investment and facilitate FDA approval. This summary was automatically generated using LLM.

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Mental Health IT Medical Specialization 52

Physician's Weekly

JUNE 19, 2025

About 3 in 10 adults reported not taking their medicines as prescribed at some point between July 2022 and July 2023 because of the cost, according to a KFF survey. Back in February, we asked you, our listeners, to tell us how you’ve managed when your prescriptions got really expensive. Lynne Johnson is our operations manager.

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FDA Law Blog

DECEMBER 3, 2023

Below, we provide a high-level summary of the Final Guidance, focusing on the legal and regulatory updates from the May 2023 draft guidance. CMS will require participating manufacturers to submit and attest to this ownership information in the Health Plan Management System (HPMS). Phase-in Memorandum at 2. Final Guidance at 27.

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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.

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Complication Patient-Centered Management Patients 52

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.

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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.

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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.

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Illness IT Patient-Centered Patients 109

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.

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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?

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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.

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GeriPal

APRIL 20, 2023

Alex: But the longer title’s Ethno-Geriatrics and Special Populations. In the United States in 2023, the truth of the matter is you don’t need very many individual risk factors to become homeless. Margot: Yes. But the folks who are homeless are much more likely to have a really high burden of these individual risk factors.

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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.

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Common Sense Family Doctor

MAY 27, 2025

There is good evidence that federal nutrition programs such as the Supplemental Nutrition Assistance Program (SNAP, previously known as "food stamps") and Special Supplemental Nutritional Program for Women, Infants, and Children (WIC) improve health.

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Physician's Weekly

JUNE 12, 2025

During an interview on CNN’s “State of the Union,” Russell Vought, the administration’s director of the Office of Management and Budget, framed Medicaid as sagging under the weight of improper payments. “Look, one out of every $5 or $6 in Medicaid [payments] is improper.” billion were improper.

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Government Provider Insurance IT 52

GeriPal

SEPTEMBER 14, 2023

By the year 2000, everyone will be in a Medicare managed care plan.” For our patients, it really is much more patient-centered to able to do symptom management, and to do IV antibiotics, and all those things at home, instead of having them come in. Bruce: That would definitely be considered a macroaggression in 2023.

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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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