FDA Law Blog

MARCH 7, 2024

NORD’s announcement followed in the footsteps of European rare disease patient organization, Eurodis , who had celebrated the first Rare Disease Day the year before. What started as a day has — due to its popularity and the persistent efforts of patients and industry — evolved into a week-long event. recognition of Rare Disease Day.

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Government Community Specialization Education 69

PEMBlog

MAY 31, 2023

When we think of managing agitated patients we think of medicines – but that shouldn’t be our first option. Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. Government. These articles will take another look at the content included in this episode. PMID: 36948291.

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Management Patient-Centered Finance Transportation 89

FDA Law Blog

FEBRUARY 18, 2025

23, 2025), DEA reviewed evidence from an administrative hearing and upheld the Administrative Law Judges (ALJs) recommended decision to revoke the registration of a pharmacy that DEA alleged dispensed controlled substances to patients without resolving numerous red flags of diversion. Whats the take away?

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Government Specialization Patients IT 69

Permanente Medicine

MAY 20, 2025

Khang Nguyen, MD, chief transformation officer of the Southern California Permanente Medical Group, discusses how AI can increase clinicians’ joy in medicine and improve patient outcomes with Chris Grant, chief operating offer and executive vice president of Kaiser Permanente, The Permanente Federation, and host of the Permanente Medicine Podcast.

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Patient-Centered Patients Medical IT 52

Blood, Sweat, and Tears

MAY 24, 2022

You have to be able to laugh at situations, the system, the government, people and especially yourself (Mostly yourself). I was so burnt out, dragging my feet, lugging my head from patient to patient. But What broke the monotony was a special nurse with a special personality who I laughed my head off with during every call.

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Referral Community Patients Specialization 52

FDA Law Blog

SEPTEMBER 22, 2022

The JAMA editorial notes that there are few Park cases for two primary reasons: [The government] may lead. While strict liability criminal statutory schemes are an exception to that rule, we don’t agree that the government should bring a Park case just because it can.

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Private Practice Government Individual Specialization 59

FDA Law Blog

MAY 7, 2025

Two recent cases from the Fifth and Seventh Circuits, however, support the legality of these arrangements in the absence of the government proving certain circumstances. Physicians had ultimate control and exercised independent judgment over their patients healthcare decisions. Mallory , 988 F.3d 3d 730 (4th Cir. Medicare or Medicaid).

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FDA Law Blog

APRIL 6, 2025

We are excited by Naomis strong passion for solving complex regulatory issues and ensuring patient stakeholders have a voice in the drug development process. Before her legal career, Julie worked as a nurse practitioner specializing in neurosurgery and infectious diseases.

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IT Nurse Practitioner Patient-Centered Government 59

PEMBlog

MAY 17, 2023

Furthermore, the connection between physical and functional symptoms is inextricably linked in many patients. Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. Government. Why then do we persist with the “is it medical/organic or psych” question?

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Patient-Centered Mental Health Management Finance 68

FDA Law Blog

MARCH 6, 2024

His practice supports clients throughout the life sciences from biotech startups and multinational pharmaceutical companies to CROs and academic researchers to patient advocacy organizations. We can offer our readers a special discount for the event. The discount code is S10-896-896L24.S. Details on the conference can be found here.

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Management Manufacturing Government Specialization 59

FDA Law Blog

JUNE 7, 2023

The cases were both brought under the False Claims Act (FCA), the Civil War-era law that the government uses to claw back funds it pays out to parties that overbill federal programs. The FCA incentivizes whistleblowers to come forward by awarding them a cut of any recovery. What was SuperValu all about?

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Government Patient-Centered IT Manufacturing 40

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. It was alleged that other employees administered the medication to patients even after observing signs of tampering, although no patients were reported harmed.

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GeriPal

JULY 19, 2024

What hasn’t been shown, Eric, is that if you apply tools like this, clinical outcomes down the road are better for patients. I don’t have access to change the levers of government. They’re dedicated, committed, they’re there for their patients and they understand it’s really important.

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Screening Primary Care Patient-Centered IT 120

FDA Law Blog

MAY 3, 2021

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. Incomplete and inaccurate records currently subject registrants to civil monetary penalties of up to $15,691 per violation.

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Management Manufacturing Specialization IT 52

FDA Law Blog

MAY 3, 2021

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. Incomplete and inaccurate records currently subject registrants to civil monetary penalties of up to $15,691 per violation.

Management 40

Management Manufacturing Specialization IT 40

ABIM

JUNE 4, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. See the discussion on the Special Consideration IMG (International Medical Graduates) Pilot Pathway below.) Community Practice in ABIM Governance* Erica N.

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Diabetes Board-Certified Telehealth Government 52

ABIM

JUNE 11, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Community Practice in ABIM Governance* Erica N. Upgrades to the ABIM website and Physician Portal for 2025 designed to make it easier for both physicians and the public to find information.

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ABIM

MAY 30, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Lieske, MD , raised concerns about how new government policies may affect international medical graduates and health equity work at ABIM. Community Practice in ABIM Governance* Erica N.

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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. This region governs essential behaviors like the circadian clock, sleep, energy balance , and feeding.

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Provider Medical Complication Diabetes 110

GeriPal

SEPTEMBER 5, 2024

And Bill Andereck is still haunted by the decision he made to have the police break down the door to rescue his patient who attempted suicide in the 1980s, as detailed in this essay in the Cambridge Quarterly of HealthCare Ethics. The patient case. I think the theme is more saving someone’s life and the regret that follows.

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Patients IT Patient-Centered Hospital 98

PEMBlog

MAY 24, 2023

Patient that are agitated should always be treated with dignity and respect. Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. Government. Structured team approach to the agitated patient in the emergency department. Emerg Med Clin North Am. 2009 Nov;27(4):655-67, ix.

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Management Patient-Centered Physicals Finance 54

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. I am passionately against bad care and there is a lot of bad hospice care that preys on highly vulnerable patients and is unnecessary. Eric: Great.

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IT Provider Patients Families 115

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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Supply Chain Manufacturing Government Hospital 59

Doctors for America

MAY 5, 2025

FOR IMMEDIATE RELEASE Doctors for America PO Box: 21161 2300 18th St NW Lbby Washington, DC 20009-9996 May 5, 2025 Doctors, Local Governments File Brief to Defend Reproductive Health Care Privacy Rights Brief Argues that Upending HIPAA Privacy Rights Would Contradict Decades of Established Precedent WASHINGTON, D.C.

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Government Medical Student Community Patients 52

Doctors for America

MAY 30, 2025

FOR IMMEDIATE RELEASE Doctors for America PO Box: 21161 2300 18th St NW Lbby Washington, DC 20009-9996 May 30, 2025 Coalition Acts to Protect Pregnant Patients’ Federal Right to Emergency Care, Including Abortion By Intervening in a Federal Challenge to EMTALA, Doctors for America Seeks to Protect Health and Lifesaving Care WASHINGTON, D.C.

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Patients Medical Student Patient-Centered Emergency Room 93

GeriPal

MARCH 16, 2023

We have two authors, books, op-eds, prolific authors, and today’s podcast is a two-part special. Rosanne: I think I was motivated by the number of times patients asked me to get rid of their pot-bellies, quite honestly. And my patients started coming in talking about why didn’t you ever recommend that to me?

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IT Healthcare Professional Healthcare Transportation 106

GeriPal

DECEMBER 7, 2023

I actually wonder though, since we’re on a GeriPal broadcast, I think that people are under emphasizing the special risk of older people. And that’s a good thing to share with an older patient or client that making decisions about your activity. So how are your patients going to deal with extreme heat and cold?

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Healthcare IT Education Community 130

FDA Law Blog

JUNE 21, 2022

This provision adds nothing substantive to the OTC hearing aid regulatory scheme—it merely tells FDA that it has 30 days from enactment of the user fee legislation to issue its final rules governing OTC hearing aids. Directing FDA to issue rules isn’t out of the ordinary.

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IT Provider Government Patients 52

GeriPal

AUGUST 15, 2024

Ongoing reports from patients about anti-Asian hate experiences Should clinicians screen for Anti-Asian hate? This question, while providing an opportunity to talk about direct and indirect experiences, can be asked of all patients, and opens the door to conversations about anti-semitism, islamophobia, or anti-Black racism.

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Mental Health Community Screening IT 118

GeriPal

APRIL 20, 2023

Today we talk with Margot Kushel about how we got here, including: That sense of powerlessness as a clinician when you “fix up” a patient in the hospital, only to discharge them to the street knowing things will fall apart. It was in the mid-nineties, and about half of the patients that we cared for in the inpatient service were homeless.

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Mental Health IT Community Individual 124

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.” Care Ecosystem.

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Patient-Centered IT Families Family 126

Doctors for America

JUNE 23, 2025

As a nonpartisan organization of thousands of physicians and medical trainees committed to health justice, we bear witness to the trauma these policies inflict on our patients, our communities, and the healthcare system as a whole. – Prevent the use of patient information or healthcare settings to facilitate immigration enforcement.

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Medical Student Mental Health Healthcare Patient-Centered 89

GeriPal

JULY 20, 2023

Clinicians could care for patients across state lines, could prescribe opioids without in person visits, could bill at higher rates for telemedicine than previous to the pandemic. Many patients benefited, not only those isolating due to covid, but also patients in rural areas, patients who are homebound, and many others.

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Telemedicine Telehealth Patient-Centered Board-Certified 73

Doctors for America

MAY 21, 2025

These attempts by the State of Texas to interfere in HIPAA privacy protections compromise the very core of medical ethics – open communication and trust between a patient and their doctor,” said Christine Petrin, MD, MPH, Board President of Doctors for America. Two major U.S. Two major U.S. In the case, Texas v.

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Government Medical Student Community Medical 83

FDA Law Blog

MAY 23, 2025

During the first Trump Administration, the 10-for-1 Rule seemed to be more in name only when it came to FDA, whereas this administration seems more intent on its deregulatory approach, so we expect it to have more of an impact on FDA governance this time around. specific patient populations, disease states, and procedures).

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Manufacturing Specialization IT Provider 59

Doctors for America

APRIL 29, 2025

The president and his cabinet’s decisions directly impact how we practice and care for our patients. However, this assessment comes with alarm – essential services our patients rely on and that we as clinicians need to provide high-quality, evidence-based care have been obliterated by seemingly haphazard decision-making.

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