FDA Law Blog

MAY 8, 2023

In February 2020, FDA granted a de novo classification request (DEN190040) for software intended to assist medical professionals in the acquisition of cardiac ultrasound images and that included a PCCP for future software modifications. Performance evaluation protocols : The MP should include plans to verify and validate modifications.

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FDA Law Blog

MAY 3, 2021

In July 2020, DEA stated as a justification for increasing registration fees that it planned to increase the number of scheduled regulatory inspections and investigations. 44,710, 44,716 (July 24, 2020). Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. Background. 21 U.S.C. § 21 U.S.C. §

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FDA Law Blog

MAY 4, 2023

In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories. This draft guidance builds on recommendations that FDA initially developed early in 2020, in response to the COVID-19 challenges (see our blog post on these recommendations here ).

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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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FDA Law Blog

JULY 10, 2023

Understanding the Traditional 510(k) Review Timeline There are three types of Premarket Notification 510(k)s: Traditional , Special , and Abbreviated. By Day 100 If MDUFA Decision is not reached by Day 100, FDA provides Missed MDUFA Decision Communication that identifies outstanding review issues. 510(k) Time to MDUFA IV Decision.

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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. Emergency Care Plans and Advanced Directives Many DMD patients will arrive with comprehensive emergency care plans or letters from their providers. 2020 Jun 5;15(1):141.

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FDA Law Blog

MAY 3, 2021

In July 2020, DEA stated as a justification for increasing registration fees that it planned to increase the number of scheduled regulatory inspections and investigations. 44,710, 44,716 (July 24, 2020). Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. Background. 21 U.S.C. § 21 U.S.C. §

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Management Manufacturing Specialization IT 40

FDA Law Blog

JUNE 23, 2021

For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. Over the years, this function expanded to cancer (renamed the Office of AIDS and Special Health Issues) and, ultimately, all serious and life-threatening diseases (dropping the AIDS nomenclature).

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Patients Patient-Centered Clinic IT 52

GeriPal

JANUARY 12, 2023

Number three, this specialized prepared environment that promotes safe mobility and cognitive stimulation and delirium prevention, so sort of environmental changes. So the system drives the providers to deliver age friendly care. And the ACE unit processes provide the blueprint on how to make progress. Kellie: So ideally, yes.

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Physician's Weekly

JUNE 19, 2025

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. “We step into places where other providers may not, and geriatrics is a prime example of that.”

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Medical Xpress

JUNE 16, 2025

The content is provided for information purposes only. Citation : Texas invests $50M in psychedelic drug research to treat addiction (2025, June 16) retrieved 16 June 2025 from [link] This document is subject to copyright. Your feedback is important to us. However, we do not guarantee individual replies due to the high volume of messages.

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Mental Health IT Medical Specialization 52

Medical Xpress

JUNE 16, 2025

What is known is that special cells in the eye called intrinsically photosensitive retinal ganglion cells (ipRGCs) detect blue light and send signals to the SCN to reset the clock. The content is provided for information purposes only. Your feedback is important to us.

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Provider Medical Complication Diabetes 110

ABIM

JUNE 4, 2025

See the discussion on the Special Consideration IMG (International Medical Graduates) Pilot Pathway below.) Special Consideration IMG Pilot Pathway* In August 2024 , the ABIM Council proposed a pilot model for exceptionally qualified IMGs pursuing accredited subspecialty fellowship in the U.S.

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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. They can use their training and privilege to advocate for meaningful policy reform.

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GeriPal

JANUARY 25, 2024

Summary Transcript Summary In a JAMA 2020 systematic review of palliative care for non-cancer serious illness, Kieran Quinn found many positives, as we discussed on our podcast and in our editorial. With their regular providers? The article we discuss today, also published in JAMA , addresses these two gaps. In their communities?

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Patient-Centered IT Illness Patients 122

ABIM

MAY 30, 2025

A workgroup convened in 2020 found that the existing practice categories candidates could choose were inadequate to the real scope of community practice and proposed updates drawn from the American Medical Association and the Diplomate Professional Profile.

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ABIM

JUNE 11, 2025

A workgroup convened in 2020 found that the existing practice categories candidates could choose were inadequate to the real scope of community practice and proposed updates drawn from the American Medical Association and the Diplomate Professional Profile.

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FDA Law Blog

APRIL 8, 2024

MRAP would provide oversight of an accreditation body which would conduct assessments—paid for by the manufacturer—based on criteria developed by the MRAP. Unfortunately, the White Paper does not provide further analysis on the generic sterile injectables and instead refers back to FDA’s analysis from 2013-2017.

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GeriPal

MARCH 30, 2023

This week we’ve invited three guests to share their stories about storytelling that’s written for healthcare providers. Since my mom died in 2020 until I wrote this piece in the fall of last year, I had not ever expected or intended to write about my experience. It feels special to me. This was in May of 2020.

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IT Patient-Centered Patients Healthcare 96

GeriPal

FEBRUARY 8, 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. 2023.11.004.

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GeriPal

APRIL 10, 2025

Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it. primary palliative care interventions seem to fail, whereas specialized palliative care interventions have a relatively robust track record of success. Why do so many (most, all??)

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Patient-Centered IT Hospital Patients 77

GeriPal

FEBRUARY 20, 2025

Summary Transcript CME Summary Trauma is a universal experience, and our approach as health care providers to trauma should be universal as well. I’m just thinking we all went through a major traumatic event in 2020 and the subsequent years. So we all went through a pandemic. I guess that’s an event.

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IT Patient-Centered Individual Screening 67

GeriPal

DECEMBER 7, 2023

Big heat waves in England in 2020, 2,224 excess deaths in the obits over the age of 65. I actually wonder though, since we’re on a GeriPal broadcast, I think that people are under emphasizing the special risk of older people. What do we do to very concretely provide heat shelters and cool shelters?

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FDA Law Blog

JUNE 21, 2022

Back in the 2017 user fee package, the FDA Reauthorization Act (also called “FDARA”), Congress set forth a process for establishing a category of OTC hearing aids—hearing aids that may be sold directly to patients without the intervention of a medical provider.

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IT Provider Government Patients 52

GeriPal

APRIL 21, 2022

To the deeper emotions – of loss and grief, of wonder and transcendence – that are at the heart of the complex care we provide. I had planned to start doing in-person poetry sessions with cancer patients at the beginning of 2020. So beginning, literally April 1, 2020 until now I started with one poetry recession a week.

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Patient-Centered IT Community Illness 93

GeriPal

DECEMBER 21, 2023

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.” Eric: Okay.

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Physician's Weekly

JUNE 12, 2025

An “improper” payment refers to payments made erroneously to beneficiaries and their providers or without sufficient documentation. From 2017 to 2019, during Trump’s first term, Blase served as Trump’s special assistant for economic policy. The White House did not respond to an inquiry for this article.

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Government Provider Insurance IT 52

GeriPal

JULY 14, 2022

This was the opening paragraph that I wrote in March of 2020 when introducing a podcast we did with Dr. Jim Wright , the medical director at Canterbury Rehabilitation and Healthcare Center in suburban Richmond. That was his literally his life during those spring months of 2020 and it scared the hell out of me. . This is Eric Widera.

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GeriPal

SEPTEMBER 14, 2023

2020 Hospital at Home-Plus: A Platform of Facility-Based Care. And we would provide ongoing longitudinal care to them in the home, much like the Mount Sinai Visiting Doctors programs, and other programs like that. And the treatments are different than what hospice might provide in the home setting. Annals of Int Med.

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FDA Law Blog

MAY 13, 2025

Weve blogged about Most-Favored-Nation (MFN) drug pricing and how the new EO goes well beyond the 2020 order and questions we have. Given that the provision in the May 12 EO may be a rehash of what occurred in 2020, we thought it would be helpful to provide a bit of history and background on personal importations.

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Manufacturing IT Individual Provider 59

FDA Law Blog

NOVEMBER 8, 2023

Koblitz & Philip Won — The first anniversary is always special. The rule also aimed to provide “consumers with perceived mild to moderate hearing loss with improved access to devices that meet their needs and are less expensive than current options.” By Jeffrey N. Gibbs & Sara W. However, FDA missed that deadline.

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Utilities IT Engineering Appointment 64

Physician's Weekly

JUNE 12, 2025

The House bill would instead require every new or returning policyholder each year to provide information on income, household size, immigration status, and other factors, starting in 2028. Also, as soon as the end of this year, a special enrollment period the Biden administration created would be done away with.

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