FDA Law Blog

OCTOBER 5, 2022

CDRH’s website provides a link to request access to the CCP ( here ). According to CDRH’s website, “When you send a CDRH 510(k) submission (traditional, special, and abbreviated 510(k)s) for review, your official correspondent can monitor the FDA’s progress online in a simple, concise format.”

Electronics 59

Electronics Utilities Specialization IT 59

PEMBlog

SEPTEMBER 20, 2023

Special thanks to Dr. Stephen Freedman, from the University of Calgary, for reviewing this post as well – he brought some practical feedback to the table. Lack of utility of abdominal x-rays in the evaluation of children with constipation: Comparison of different scoring methods. 2017;186:87-94.e16. PMID: 28457526.

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Diagnosis Diagnose Hospital Clinic 122

FDA Law Blog

MAY 27, 2024

Jennifer’s combination of experiences as in-house counsel for both large and start-up companies as well as outside counsel provides clients invaluable expertise and problem-solving skills. She also specializes in medical device software and digital health.

Manufacturing 59

Manufacturing Management Utilities Relationship 59

FDA Law Blog

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

Clinic 64

Clinic Clinical Practice Provider Utilities 64

PEMBlog

AUGUST 30, 2023

Special thanks to Todd Florin, MD, MSCE who contributed to this post – he is also an expert on respiratory and infectious emergencies. Drivers of CXR overuse are myriad and can be thought of at the system, provider, and patient levels. But it’s just a CXR right?

Asthma 52

Asthma Electronics Utilities Clinical Practice 52

Imperial Center Family Medicine

MAY 26, 2025

Limiting these cholesterol-raising oils is just as important as utilizing healthier options in your cooking. Save this tropical oil for special occasions versus everyday cooking when managing cholesterol through diet. Our compassionate physicians provide complete cholesterol screenings and treatment plans customized to your needs.

Management 52

Management Screening Family Medicine DO 52

The Clinical Problem Solvers

DECEMBER 16, 2020

Our esteemed publications should ensure that investigations that utilize racial variables follow these guidelines before being published. Examining the Potential Impact of Race Multiplier Utilization in Estimated Glomerular Filtration Rate Calculation on African-American Care Outcomes. 2019;322(2):113-114. doi:10.1001/jama.2019.577

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

The Motivated MD

DECEMBER 18, 2024

Most don’t understand that, unless you can shell out a substantial downpayment, your home is often accompanied by higher insurance costs, more square footage then expects nicer furnishings, increased utility costs, and often the expenses associated with repairs or remodels.

Finance 52

Finance Insurance Individual IT 52

The Motivated MD

NOVEMBER 26, 2024

There are also homeowners insurance costs, property taxes, flood insurance (depending on where you live), any upgrades to the home, utilities (sometimes included in rent expenses), upfront costs to include a downpayment, and closing fees. Use the rules provided above to determine what is right for you.

Finance 52

Finance Insurance Individual Medical Advice 52

GeriPal

JULY 19, 2024

Joe 03:55 You know, my thoughts are screening is important for a variety of reasons, and certainly Doctor Boris and Soo and Anna, Doctor chodos can provide a lot greater clinical insight than I. There has to be effective support provided behind any type of screening strategy in order for it to truly be effective. Joe, your thoughts?

Screening 120

Screening Primary Care Patient-Centered IT 120

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.

Board-Certified 52

Board-Certified Provider Government Management 52

Physician's Practice

JUNE 20, 2025

Focus on providing optimum patient care and financial success will follow Rules are made for a reason and should be followed. Focus on providing optimum patient care, and the financial success will follow. Breaking them can lead to problems, fines, and even incarceration. Focus on making the product great, and the profits will follow.

Management 52

Management Patient-Centered Appointment Patients 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. They can use their training and privilege to advocate for meaningful policy reform.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

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. Calac, Victor A. Can you refer your patient there? 3.

Community 52

Community Patient-Centered Emergency Room Medical 52

The Motivated MD

SEPTEMBER 19, 2024

’ Though it often does not come with the attending salary, medical trainees are getting paid to perform a service, and hospitals provide retirement plans to these individuals. Since these savings are so important, automated savings is another avenue to utilize. My children’s 529 has an option to ‘auto contribute.’

Finance 52

Finance Individual Education Healthcare Professional 52

GeriPal

JANUARY 25, 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. David: Yeah.

Patient-Centered 123

Patient-Centered IT Illness Patients 123

GeriPal

SEPTEMBER 1, 2022

In day-to-day practice, It’s hard to imagine providing excellent hospice or palliative care services without access to a team social worker. And I think that’s when I got hooked on how do we improve care, in my case again, for kids and families, but also for us, the providers. I can figure out how to provide care in this way.

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IT Families Family Clinic 102

FDA Law Blog

MAY 11, 2023

Where the generic sponsor has carved-out the specific indication identified in the Orange Book as covered by the method of use patent, the Government argues, the generic labeling “cannot provide the requisite evidence of specific intent to induce infringement.” Whether the Court takes up Teva v. GSK is still up in the air.

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Government Manufacturing IT Utilities 72

GeriPal

JUNE 5, 2025

Despite these substantial needs, specialized palliative care beyond hospice is rare in nursing homes. How to think about primary and specialized palliative care in this setting. So the palliative care service doesn’t necessarily need to provide those potentially. Many also suffer from distressing symptoms like pain.

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Nurse Practitioner Referral Consulting Board-Certified 78

GeriPal

AUGUST 25, 2022

Eric: Alex, we have a super special today. We’ve got a hospice super special. Alex: We have a hospice super special day. Eric: We have a smorgasbord, if you will, of papers that got published recently around hospice, and that’s why we’re calling it a hospice super special. -@AlexSmithMD. Transcript.

Families 107

Families Family IT Patients 107

PEMBlog

MARCH 27, 2024

My special guest podcaster, Emily Groopman, is an actual Pediatric Geneticist in training and we hope that you will find this episode useful. She did her MD/PhD at Columbia University, where she investigated the diagnostic utility of exome sequencing for kidney disease. It is not the job or the expectation of the EM provider.

Consulting 59

Consulting Individual Families Family 59

GeriPal

APRIL 14, 2022

Adapting Palliative Care Skills to Provide Substance Use Disorder Treatment to Patients With Serious Illness . We got some really special guests with us. And that’s a lot easier if all providers were X waivered too. Learn about using the low dose buprenorphine patch: . Transcript. Eric: Welcome to the GeriPal Podcast.

Illness 103

Illness Patient-Centered IT Patients 103

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??)

Patient-Centered 78

Patient-Centered IT Hospital Patients 78

GeriPal

APRIL 28, 2022

So when I make a cartoon, usually I’m sending it to a few people before it’s ever seeing the light of social media, to make sure it’s not going to come across as insensitive either to patients or to my fellow providers. And so here’s a picture of four healthcare providers behind bars. Like, oh no, I said it.

IT 145

IT Hospital Patients Illness 145

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.

Family Medicine 40

Family Medicine DO Families Family 40

New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

Eating fruit provides excellent health benefits and is part of a healthy plate. Fruits provide nutrients vital for health and maintenance of your body. Fiber containing foods such as fruits help provide a feeling of fullness with fewer calories. Folate (folic acid) helps the body form red blood cells.

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Referral Family Medicine DO Primary Care 40

GeriPal

JUNE 9, 2022

We talk with Kate about how despite how far we’ve come in palliative care research, we still don’t have answers to some fundamental questions, such as: Who should get specialized palliative care? And I actually think the cool thing about a needs-based approach would allow us to better utilize the service. By diagnosis? By prognosis?

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Consulting Patient-Centered Diagnosis IT 100

Annals of Family Medicine

NOVEMBER 20, 2024

The University provided guidance on how to recruit youth ambassadors, train community members and staff to accomplish the goals of the project, to decrease the vaccine hesitancy rate and increase COVID-19 vaccination rates among youth through education/outreach from respected individuals and organizations from local communities.

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Community Utilities Vaccination Education 130

GeriPal

MARCH 28, 2024

Kate: The problem is we communicate late, we share prognosis late, we elicit goals and values late, so all the time while they’re in the ICU getting prolonged intensive care, we don’t really know that we’re providing goal concordant care, so we wanted to nudge it a little upstream. I’m just stunned even writing that!

Consulting 116

Consulting Patient-Centered Patients IT 116

GeriPal

APRIL 6, 2023

To provide context, we are joined by Karen Steinhauser, a social scientist at Duke who has been studying spirituality for years (and published one of the most cited papers in palliative care on factors considered important at the end of life , as well as one of my favorite qualitative papers to give to research trainees ).

IT 99

IT Patient-Centered Families Family 99

GeriPal

JULY 13, 2023

It’s really special to be here and to be talking about this paper, which was really important to Randy. And if I remember that study correctly, it was priming both patients and providers in the outpatient setting to do goals of care conversations. We also provided reassurance that this is not a long conversation.

Patient-Centered 84

Patient-Centered IT Patients Hospital 84

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.” Think about CPC+.

Patient-Centered 126

Patient-Centered IT Families Family 126

GeriPal

JULY 20, 2023

What was life for you as a provider pre-pandemic? We were the highest utilizers of telemedicine in the whole UCSF health system at that time which we’re very proud of. And so we’re able to provide access to those patients that may be home-bound or home limited or have a lot of struggles to get in.

Telemedicine 73

Telemedicine Telehealth Patient-Centered Board-Certified 73

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.

Utilities 64

Utilities IT Engineering Appointment 64

Doctors for America

APRIL 29, 2025

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. Commitment to Transparency: Under President Trump, HHS and FDA have rapidly become less transparent.

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Medical Student Patients Medical Individual 52