FDA Law Blog

OCTOBER 2, 2024

As both these categories of changes are currently permitted via a PMA supplement, and the goal of FDORA is to provide an alternative to the need for such supplements, we would expect major changes and modifications to intended use to be permissible via a PCCP as long as the device remains safe and effective without any change.

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Medical Specialization Manufacturing IT 59

FDA Law Blog

MAY 8, 2023

FDA recommends that PCCPs specify only a “limited number” of modifications but does not provide a limit on the number of modifications that can be included. If the proposed performance evaluation methods are different from the original methods used, the manufacturer should describe the differences and provide a justification for the changes.

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Manufacturing Provider Medical IT 98

The Clinical Problem Solvers

DECEMBER 16, 2020

19:05 Clarifying the “ethics vs science” argument and critiquing research techniques 22:00 Resurgence of race-based speculation in COVID-19-related research 25:57 Implantation of ideas about innate racial inferiority within medicine 28:32 Will removal of race from algorithms potentially harm our patients?

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Clinic Education Clinical Practice Patient-Centered 52

FDA Law Blog

JUNE 28, 2021

On June 26, 2021, during the Minnesota legislature’s special session, the Minnesota House of Representatives passed HF33, an omnibus health and human services bill. If enacted, Article 5, Section 6 of HF33 would provide for a reduction to the State’s opiate product registration fee. 151.066, Subd.

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Hospital Manufacturing Specialization Medical 52

FDA Law Blog

JUNE 22, 2022

This matter is the latest in a recent string of large monetary settlements between the government and health care providers involving employee diversion. Lax Controls Provided Employees with Opportunity to Divert. In short, the employees were provided the opportunity to not only commit the crimes but that they went undetected.

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Annals of Family Medicine

NOVEMBER 20, 2024

Some family physicians pursue additional training to become certified as having additional competence in ‘Care of the Elderly’ and/or apply for "focused practice" status to care for older patients. These providers mainly practiced in team-based models and often participated in comprehensive practice.

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The Clinical Problem Solvers

APRIL 5, 2022

During this episode, we gained insight from special guests Dr. Margot Kushel and Mr. Bobby Watts about what brought them into their fields, how their work reaches the most marginalized, and what can be done at the community and structural level to address homelessness. Can you refer your patient there? 3. Calac, Victor A.

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Community Patient-Centered Emergency Room Medical 52

The Clinical Problem Solvers

FEBRUARY 8, 2023

There is a special emphasis on the use of public health models that prioritize harm reduction and person-centered care to prevent drug-related fatalities and curb the opioid epidemic along lines of race and class. This segues into a conversation about the legacy of the war on drugs and today’s racial inequities in opioid addiction treatment.

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Community Patient-Centered Mental Health Board-Certified 52

FDA Law Blog

JUNE 10, 2024

The hospital also “entered into a Memorandum of Agreement with the DEA requiring Palomar Health to undertake additional measures to increase security, implement specialized training, and to handle controlled substances properly and safely.” Palomar Health self-disclosed to DEA that one of its employees may have diverted the fentanyl.

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Management Patient-Centered Hospital Healthcare 59

GeriPal

MARCH 24, 2023

I’m very proud of the work that we do every day and we take care of patients and families no matter where they live or who they are to help them meet their end of life goals. She happened to focus on some specific for-profit hospice providers. So hospices have been around for decades, generally provide higher level care.

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IT Provider Patients Families 115

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.

Illness 109

Illness IT Patient-Centered Patients 109

GeriPal

AUGUST 25, 2022

Second, Hospice was originally designed for patients with advanced cancer, but the fastest growing admitting diagnosis is dementia. Krista Harrison found , to her surprise, that caregivers of people with dementia who died rated hospice as well as similar patients without dementia who died on hospice. AlexSmithMD. Transcript.

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Families Family IT Patients 107

Physician's Weekly

JUNE 19, 2025

Bob’s journey here begins in 2019 — the first day of high school for his daughter, Mary. This is a, you know, board certified pediatric neurologist who’s been seeing this patient for years. But a lot of patients say, like Bob would: My doctors and I had already DONE all this checking. Dan: We see it all the time.

Insurance 52

Insurance IT Board-Certified Medical 52

GeriPal

APRIL 26, 2024

Who spends the most time with the patient in the infusion center? Some numbers to back it up: ELNEC has trained more than 48,000 providers in a train the trainer model Over 1.5 We started writing this paper in 2019 actually. Eric: So not from the patient perspective or family, but from the provider perspective?

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Patient-Centered IT Patients Consulting 121

FDA Law Blog

MAY 13, 2025

Wasserstein We are still parsing through the May 12 Executive Order (EO), Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients and impacts this may have on the pharmaceutical industry. By Dara Katcher Levy & Sara W. Koblitz & Jeffrey N. it is illegal to import. 70,796, 70,800 (Dec. consumers.

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Manufacturing IT Individual Provider 59