FDA Law Blog

MARCH 7, 2024

Instead, FDA recommended that sponsors “limit the use of a DMC” to clinical studies in which safety concerns may be unusually high, such as studies that compare rates of mortality or major morbidity or involving a potentially fragile or high-risk population, or large, multi-center studies of long duration.

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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

GeriPal

JULY 19, 2024

Joseph Gaugler is the Director of the Center for Healthy Aging and Innovation at the University of Minnesota, director of the BOLD Public Health Center of Excellence on Dementia Caregiving, and Editor-in-Chief of the Gerontologist. Should it? If so, how do we screen and who do we screen? Who should get it if anyone? Soo 00:32 Thanks.

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Screening Primary Care Patient-Centered IT 119

FDA Law Blog

FEBRUARY 28, 2022

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ).

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Patients Clinic Medical Patient-Centered 52

GeriPal

MARCH 14, 2024

This simple challenge was focused on putting ourselves in the shoes of our patients with dysphagia who are prescribed thickened liquids. And I think that we’re at this kind of crossroads right now in dysphagia, and dysphagia management where our patients are suffering. We revisit it, and make things better for our patients.

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IT Hospital Patient-Centered Individual 124

CDOCS

MAY 4, 2021

Without this additional skill set and post graduate training I simply could not deliver the results that my patients deserve. & A healthy 46-year-old patient who has lived for over 30 years with missing bilateral maxillary incisors desired a fixed solution to his problem.

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Patient-Centered Patients Manufacturing Provider 52

FDA Law Blog

AUGUST 23, 2023

More recently, use of wearable sensors and applications running on mobile devices (Apps) by study participants has introduced new questions on how to incorporate DHTs into the study, and what information is needed to verify and validate that they are fit for purpose in the study.

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Patient-Centered Clinic Medical Utilities 52

FDA Law Blog

JANUARY 26, 2022

FDA alleged that because the TV ads contained representations or suggestions relating to Emgality’s indication for use, they were required to include risk information as well adequate provision for the dissemination of the PI or a brief summary as required by 21 C.F.R.

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IT Education Utilities Patient-Centered 40

FDA Law Blog

APRIL 23, 2023

This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources. The goal is to select similar patients in the treatment and external control groups. The Draft Guidance also states that sponsors must include in their marketing applications relevant patient-level data for both arms.

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Patient-Centered Clinic Patients Provider 49

Physician's Practice

JUNE 20, 2025

Topics Access and Reimbursement Billing & Collections Coding & Documentation Finance Law & Malpractice MedMal by Coverys Patient Engagement & Communications Staffing & Salary Technology Media Video & Interviews Podcasts Medical World News Pearls Surveys Best States to Practice Great American Physician Survey Staff Salary Survey (..)

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Management Patient-Centered Appointment Patients 52

FDA Law Blog

OCTOBER 14, 2021

Mullen — In recent years, for novel robot assisted surgery (RAS) devices, FDA’s Center for Devices and Radiological Health (CDRH) has taken the approach of clearing RAS devices for specific indications for use. These clearances are based on short-term (30 day) patient follow up. By Jeffrey K. Shapiro & Allyson B.

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Patient-Centered Healthcare Provider Manufacturing 52

FDA Law Blog

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

Permanente Medicine

JUNE 3, 2025

To address the growing demand for health care services combined with workforce shortages, utilizing health care innovations that improve patient health and restore the joy in medicine for physicians and clinicians is more essential than ever. Connecting patients with needed care quickly creates a win-win for patients and care teams.

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Utilities Chronic Condition Healthcare Patients 52

GeriPal

FEBRUARY 15, 2024

Going into patient’s homes was eye opening. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. They were stunned by the number of calls for lift assistance for older adults who had fallen. Their job was done. Alex: That is true.

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Community Transportation IT PCP 114

GeriPal

JANUARY 25, 2024

He also found gaps, including very few studies of patients with lung disease, and little impact of trials on quality of life. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. Welcome to GeriPal, Lyndsay. Lyndsay: Thank you so much.

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Patient-Centered IT Illness Patients 122

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 discussion is hosted by Ashley Cooper, Sudarshan Krishnamurthy, and new team member Gillette Pierce.

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Community Patient-Centered Mental Health Board-Certified 52

Alabama Academy of Family Physicians

FEBRUARY 19, 2025

The bill also requires the Alabama Statewide Area Health Education Center Program Office to administer and verify the eligibility of physicians claiming the credit and mandates an evaluation of the program’s success during the 2030 fiscal year.

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Insurance Management Hospital Vaccination 130

GeriPal

OCTOBER 26, 2023

Within hours of recording this podcast, I joined a family meeting of an older patient who had multiple medical problems including cancer, and a slow but inexorable decline in function, weight, and cognition. The patient’s capacity to make decisions was marginal, and his sons were shouldering much of the responsibility.

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Patient-Centered Hospital Patients IT 132

GeriPal

MAY 15, 2025

Prior podcasts on the ethics of nudging , and a different trial conducted by Kate and Scott in which the default for hospitalized seriously ill patients was to receive a palliative care consult. Clinicians were randomized to 4 groups: Usual care Prognosis nudge – EHR prompt asking, do you think your patient will be alive in 6 months?

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Patient-Centered Hospital IT Illness 116

GeriPal

JUNE 9, 2022

The National Palliative Care Research Center (NPCRC)and Palliative Care Research Cooperative (PCRC)were founded in part to meet this need. She’s also a member of the PAIR Center, which stands for Palliative Advanced Illness Research Center. What’s the role of implementation science? What is a pragmatic trial ? Transcript.

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GeriPal

OCTOBER 19, 2023

Caveat as well that RCTs should not be placed on pedestal as the only answer- often patients enrolled in RCTs do not represent real world patients – observational studies do. For a trial to have value, it should not exclude patients over age 80, or those with dementia, or patients residing in nursing homes.

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Patient-Centered IT Patients Illness 126

GeriPal

MARCH 28, 2024

And we have Kate Courtright, who’s at University of Pennsylvania, the PAIR Center. I’m just stunned even writing that! We’ve come so far as a field. This is Eric Widera. Alex: This is Alex Smith. Eric: Alex, who do we have with us today? We are at AAHPA…uh.AAHPM… Alex: Was it a long night last night? laughter] Eric: 2:30 AM.

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Consulting Patient-Centered IT Patients 115

The Physicians Foundation

MAY 20, 2025

The Physicians Foundation announces the 2025 recipient of the Drivers of Health (DOH) Fellowship Program, urges physicians to screen patients for DOH BOSTON, May 21, 2025 – Today, The Physicians Foundation reinforces its efforts to help physicians address drivers of health (DOH) to improve a person’s overall health.

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Chronic Disease Screening Transportation Patient-Centered 40

GeriPal

APRIL 10, 2025

I asked emergency medicine clinicians what they thought when a patient who is seriously ill and DNR comes to the ED, and some responded, (paraphrasing), what are they doing here? 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.

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Patient-Centered IT Hospital Patients 77

GeriPal

FEBRUARY 2, 2024

First, in our editorial, we expressed concern about the length of stay metric not being patient centric, though important for health systems focused on cost savings. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. Much more to come.

Consulting 120

Consulting Hospital Patient-Centered IT 120

GeriPal

JANUARY 20, 2023

I know you’ve been a strong advocate for nursing home patients particularly in California. Eric: Yeah, I guess in the very beginning of the COVID pandemic really highlighting the structural issues, lack of PPE, really people ignoring it outside of just the place to send COVID patients to. I hope I got that right. Jasmine: Yes.

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PEMBlog

MAY 24, 2023

Patient that are agitated should always be treated with dignity and respect. This entails utilizing the least invasive non-pharmacologic means of assisting them, before moving to physical or chemical restraints. It is also episode 2 in a 5 episode series focused on agitation in children and adolescents.

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Management Patient-Centered Physicals Finance 54

GeriPal

APRIL 6, 2023

Today we have a star-studded lineup, including Lexy Torke of Indiana University, who discusses her RCT of a chaplaincy intervention for surrogates of patients in the ICU , published in JPSM and plenary presentation at AAHPM/HPNA. These studies are important. It meets in-person, once a month, over nine sessions. The theme is death.

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IT Patient-Centered Families Family 99

GeriPal

FEBRUARY 13, 2025

How to be sensitive to the risks of stereotyping based on recommendations from the few members of the board to the many heterogeneous patients served? I’m Marie Bakitas, and I’m a professor at the University of Alabama at Birmingham and also the associate Director of the center for Palliative and Supportive Care.

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Consulting Community Patient-Centered Families 63

GeriPal

AUGUST 24, 2023

We talk with Harvey about how he defines “dignity” and how we can understand what it means to our patients. Fox gives patients hope there may be a place that illness doesn’t touch Depression is a Liar Why is Being a Patient Such a Difficult Pill to Swallow Better Patient Care Calls for a ‘Platinum Rule’ to Replace the Golden One.

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Patient-Centered Patients IT Illness 98

FDA Law Blog

OCTOBER 28, 2021

In some instances, however, this is only the first hurdle to make innovative products available to patients. In 2010, the Patient Protection and Affordable Care Act (ACA) established a mandate requiring coverage for women’s preventive services including contraceptives.

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Insurance Utilities Individual Provider 40

GeriPal

MARCH 7, 2024

But before we jump into that topic, John, do you have the song request for Alex? John: I do. It’s Jimmy Buffett’s song, Bubbles Up. It was on his last album. As you may know, Jimmy Buffett passed away in August of a rare skin cancer. When I heard Bubbles Up, I was really struck by two things. How do you see the light? You were a what?

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Provider Illness IT Healthcare 117

PEMBlog

APRIL 26, 2023

Kit Carney and Dr. Kristen Humphrey discuss gun violence, its impact on our patients and their families, as well as practical tips on advocating for safe storage of firearms, and how we can support victims of violence. I’m Dr. Carney and I am a pediatric resident at Cincinnati Children’s Hospital Medical Center.

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Family Families Mental Health Healthcare 52

BMJ

MAY 10, 2022

Family physicians and family health workers, considered reliable sources of vaccine information, have a unique position where individuals in rural and urban areas can access frequently, uninterruptedly, cheaply, and easily [2]. A sample was not selected as it was aimed to reach all 323 people working in family health centers in the district.

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Vaccination Healthcare Professional Healthcare Primary Care 40

New South Family Medicine and MedSpa

NOVEMBER 24, 2022

Direct primary care offers you and your family top-notch health care, and so much more.like a high patient and provider satisfaction with an improved quality of care. Providers at New South Family Medicine and MedSpa can address the patient's deeper needs, rather than trying to rush through a hectic day full of too-brief appointments.

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DO Family Medicine Families Family 40

GeriPal

SEPTEMBER 19, 2024

Give too much, it may cause harm (even if the higher dose had no significant side effects, it would require patients to take a lot of unnecessary additional pills as well as increase the cost.) So, what is the effective dose of palliative care? Give too little – it may not work. Jennifer 01:20 I do have a song request for Alex.

Patient-Centered 119

Patient-Centered IT Patients Hospital 119

GeriPal

JUNE 26, 2025

-Alex Smith Additional links mentioned by Tsai-Chin Cho: – Wealth shocks and mortality in the US – Change in marital status as a risk for wealth shock ** NOTE: To claim CME credit for this episode, click here ** Transcript Eric 00:11 W elcome to the GeriPal p odcast. This is Eric Widera. Alex 00:12 This is Alex Smith. Is it you, Rebecca?

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Illness Hospital IT Patient-Centered 93