FDA Law Blog

JANUARY 4, 2022

This includes a November 2020 Special Fraud Alert wherein OIG explained its enforcement focus regarding speaker programs. (We The updated Code incorporates the latest guidance from the Office of Inspector General at the U.S. Department of Health and Human Services (OIG). We blogged about the Alert here ).

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FDA Law Blog

OCTOBER 3, 2022

HHS noticed an increasing trend of illegal kickbacks in connection with speaker programs and in November 2020, the Office of Inspector General issued a Special Fraud Alert on the topic. See 42 U.S.C. 1320a-7b(b). The Alert described several factors that could potentially violate the antikickback statute.

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The Clinical Problem Solvers

JULY 25, 2019

Share Tweet Click to email a link to a friend (Opens in new window) Email Like this: Like Loading.

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The Clinical Problem Solvers

DECEMBER 16, 2020

September 8, 2020. Published online May 11, 2020. Published online July 29, 2020. Published online July 29, 2020. Published July 2, 2020. Institute for Healing & Justice in Medicine ; 2020. link] December 17, 2020. Examining and Rethinking Race Portrayal in Preclinical Medical Education.

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FDA Law Blog

JULY 11, 2023

To set the stage for this case, we need to go back to March 2020 , when a new definition of “biological product” threw the world of protein products into a tizzy. And, like it has before , the District Court of D.C. recently grappled with this very question in Ipsen v.

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The Clinical Problem Solvers

MARCH 14, 2025

These programs recognize the increasing difficulties in having to first see a community-based primary care provider before seeing a specialized psychiatrist. 2020 Nov 12;383(20):1904-1905. Diversifying your mental health outreach goes hand in hand with diversifying your providers. Grupp-Phelan, J., Mahabee-Gittens, E. Chernick, L.

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Aspiring Minority Doctor

MARCH 26, 2021

December 2020 The official plastic surgery release date was December 4, 2020 and to my delight, I received an interview! I received zero interview invites up until December, which was pretty disheartening, but I still held out hope as the official plastic surgery interview release date wouldn't be until later.

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The Clinical Problem Solvers

OCTOBER 18, 2022

Random House, 2020. Basic Books, 2022. Wilkerson, Isabel. Caste (Oprah’s Book Club): The origins of our discontents. Disclosures The hosts and guests report no relevant financial disclosures.

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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). The opioid epidemic has led DEA to take a more aggressive approach to cyclic and on-site inspections.

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FDA Law Blog

SEPTEMBER 30, 2022

Kirschenbaum — In November 2020, we blogged about a decision by the Federal District Court of Maryland dismissing a Federal False Claims Act (FCA) qui tam suit alleging that Forest Laboratories knowingly reported inflated best prices under the Medicaid Drug Rebate Program (MDRP), resulting in underpayment of rebates.

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FDA Law Blog

JUNE 22, 2022

In the second case, occurring from January to May 2020, a registered nurse, admitted to daily tampering of fentanyl vials and hydromorphone injectables wherein she removed the drugs from the vials replacing them with saline solution. DEA regulations require “adequate security” but do not specially require cameras in health care facilities.

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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). The opioid epidemic has led DEA to take a more aggressive approach to cyclic and on-site inspections.

Management 40

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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. 2020 Jun 5;15(1):141. The condition affects multiple organ systems—muscular, cardiac, and respiratory—leading to a myriad of clinical complications. Orphanet J Rare Dis.

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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.

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FDA Law Blog

MAY 4, 2023

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 ). The stability profile of the product must be considered when a product is shipped to a participant’s home.

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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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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. Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 Average Number of Industry Days to MDUFA IV Decision 54.69

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GeriPal

NOVEMBER 9, 2023

A 2020 RCT of coaching for primary care physicians shows that coaching improves burnout well-being during the intervention and has a sustained duration at 6 months of follow up. For me, I personally prefer folks that have walked in my shoes, or are specialized in, for example, academic life or something like that. Greg: Yeah. .”

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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. Eric: So can I ask also, Stephanie, you did this survey fall of 2020. And that’s to include making sure we’re using safe prescribing practices.

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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. Their growth has bolstered primary care, and, like doctors, they can specialize in particular branches of medicine.

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Vascular Physician

DECEMBER 2, 2020

The TCAR procedure also utilizes a special tool that reverses the blood flow that usually goes from the aorta to carotid and to the brain. Accessed March 10, 2020. In both techniques, a metal umbrella-like stent opens up to keep blood flowing through the artery. European Journal of Vascular & Endovascular Surgery. 2019;58:e638.

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Medical Xpress

JUNE 16, 2025

Explore further Trials using psychedelic drug to treat trauma, addiction endorsed by Texas Legislature shares Facebook Twitter Email Feedback to editors Featured Last Comments Popular Decades after 9/11, PTSD remains a persistent burden for thousands of responders 3 hours ago 0 A single enzymatic switch steers cell fate in intestinal regeneration Jun (..)

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Mental Health IT Medical Specialization 52

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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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. But what happens inside the SCN after receiving this light signal has remained largely mysterious—until now.

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FDA Law Blog

JANUARY 4, 2022

This includes a November 2020 Special Fraud Alert wherein OIG explained its enforcement focus regarding speaker programs. (We The updated Code incorporates the latest guidance from the Office of Inspector General at the U.S. Department of Health and Human Services (OIG). We blogged about the Alert here ).

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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. Epub 2020 Dec 3. Academic Psychiatry , 45 (1), 78–83. link] Castillo, E. DeBonis, K. Braslow, J. T., & Rohrbaugh, R.

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Georgetown Pediatrics & Family Medicine

FEBRUARY 10, 2023

In addition to a special day called Valentines, I would like to bring awareness to why we should keep our hearts healthy. According to the CDC, “About 697,000 people in the United States died from heart disease in 2020– that’s 1 in every 5 deaths”. Your heart is undoubtedly one of the most important organs in your body.

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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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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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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. He also found gaps, including very few studies of patients with lung disease, and little impact of trials on quality of life. I’ll say it.

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GeriPal

MARCH 30, 2023

So my piece is really reflections around caring for my mom who died toward the beginning of the pandemic in 2020, and the influence of my work in hospice and palliative care and the perspective that I brought to my care for her in that time. It feels special to me. This was in May of 2020. But it’s May 2020.

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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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GeriPal

FEBRUARY 8, 2024

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

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GeriPal

DECEMBER 5, 2024

So has a special resonance for, I think, a lot of people who are Tragically H ip fans. That was January 2020. We had, you know, it was a Monday night in June of 2020. It was my first concert without my parents. Alex 01:54 And you’ve been requesting, I think, the Tragically Hip previously, but we got denied. But that was.

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GeriPal

APRIL 10, 2025

primary palliative care interventions seem to fail, whereas specialized palliative care interventions have a relatively robust track record of success. Eric 19:30 Should we add that to special effects as our producer? Why do so many (most, all??) Should we give up on primary palliative care? So, like, I don’t.

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Patient-Centered IT Hospital Patients 77

GeriPal

FEBRUARY 20, 2025

I’m just thinking we all went through a major traumatic event in 2020 and the subsequent years. Sometimes you feel a special, like a kindred connection to a patient that may make you treat them differently also. Eric 04:55 Does it need an experience directly? So we all went through a pandemic. I guess that’s an event.

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FDA Law Blog

JUNE 21, 2022

In that legislation, Congress instructed FDA to publish proposed OTC hearing aid rules by August 2020 and to finalize those rules within 180 days after the closing of the public comment period for those proposed rules.

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