FDA Law

MAY 19, 2023

In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device. The Special Controls are silent on what would constitute appropriate levels of evidence necessary to satisfy this criterion. analytical, clinical and stability).

Specialization 40

Specialization Clinic Provider IT 40

Physician's Weekly

JUNE 19, 2025

.” In some instances, if a beneficiary can demonstrate they were misled by an employer or a federal employee, they may qualify for relief or a special enrollment period, she said. The information appears in a chart in the government’s “Medicare & You” handbook, if someone knows to look for it.

Insurance 52

Insurance Patient-Centered Government Provider 52

FDA Law

FEBRUARY 13, 2025

The guidance encourages sponsors to engage with FDA using the Q-Submission Program prior to submitting a PCCP in order to obtain FDA feedback on if the proposed modification is suitable for inclusion in a PCCP and what information the PCCP will need to include. FDA may request additional information during the review of the PCCP.

Manufacturing 71

Manufacturing Management Specialization Provider 71

The Motivated MD

DECEMBER 18, 2024

However, I think it is important to highlight some of the more frequent offenders to describe how this commonly affects individuals’ lives. Though this is in no way an exhaustive list, the following represents what I believe to be the most common culprits of lifestyle creep and financial pressures in individuals’ lives.

Finance 52

Finance Insurance Individual IT 52

The Motivated MD

NOVEMBER 26, 2024

The decision to rent or buy a home is the root of much anxiety in many individuals’ lives. I overhear individuals say things like ‘owning a home is the best investment you can make,’ and’ if you are renting, you are just ‘throwing your money away.’ As always… Stay motivated! The Motivated M.D.

Finance 52

Finance Insurance Individual Medical Advice 52

FDA Law

JULY 17, 2024

This individual will play a key role in overseeing the new integrated Hub model and helping to develop and implement its strategic agenda action plan. According to FDA, the new Hub will have special focus on products intended for smaller populations and also for diseases where the natural history is variable and not fully understood.

Patient-Centered 105

Patient-Centered Community Medical Specialty Clinic 105

Permanente Medicine

MAY 20, 2025

Contributing to this challenge is the exponential growth of information, an expanding population of older adults, and office visit documentation. Information is coming at clinicians, whether they be doctors, nurses, pharmacists, faster than ever, and there is a transparency that exists around us.

Patient-Centered 52

Patient-Centered Patients IT Medical 52

FDA Law

JULY 10, 2023

After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.

Provider 75

Provider IT Engineering Medical 75

PEMBlog

APRIL 20, 2023

A special thanks to Dr. Cristina Tarango, director of the Hemophilia Treatment Center at Cincinnati Children’s and Lisa Littner, Project Manager at Cincinnati Children’s who helped me research and write this post. Individuals on emicizumab can be dosed once a week, every 2 weeks or every 4 weeks. Factor first!

Individual 52

Individual Patient-Centered Patients IT 52

FDA Law

MAY 8, 2023

Components of a PCCP The draft guidance describes the sections that should be included as part of a PCCP and the specific information that should be included under each section. For local adaptations, information should be included addressing what “local factors or conditions warrant a local change.”

Manufacturing 98

Manufacturing Provider Medical IT 98

FDA Law

MAY 4, 2023

DCTs often include the use of digital health technologies (DHTs), which is technology that can be used to remotely capture and transmit health care information. For example, the draft guidance notes that the trial’s data management plan should include information about the multiple sources of data collection.

Clinic 59

Clinic Telehealth Provider Electronics 59

GeriPal

MAY 19, 2022

Part of my proposal is, again, that we can actually use very similar information. Really because of the structure and the nature of equianalgesic tables, similar information with simpler math, can easily be presented to our colleagues. And then again, individualizing it to the patient. I think it’s time to do that.

IT 139

IT Patients Individual Relationship 139

The Clinical Problem Solvers

DECEMBER 16, 2020

Moreover, center patients not only in discussions about individual decision-making but in constructing and drawing meaning from the research. Returning to the early literature that informs the equations reminds us that this research demonstrated racially stratified differences between Black and white cohorts. N Engl J Med.

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

PEMBlog

OCTOBER 18, 2024

Duchenne Muscular Dystrophy (DMD) is a complex and progressive disease requiring highly specialized care, especially in emergency situations. Always review the latest care plans, assess longitudinal trends in cardiac biomarkers, and consult with specialists when needed to ensure that each patient receives individualized and optimal care.

Patients 52

Patients Complication Management Consulting 52

FDA Law

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).

Patients 52

Patients Patient-Centered Clinic Community 52

FDA Law

MAY 20, 2021

At least two investigators must be present during the on-site inspection, but teams can include DEA special agents or task officers from state and local law enforcement and regulatory agencies. Registrants should consult with counsel and their Human Resources departments in deciding whether to provide this information.

Management 40

Management Consulting Provider Physicals 40

FDA Law

MAY 20, 2021

At least two investigators must be present during the on-site inspection, but teams can include DEA special agents or task officers from state and local law enforcement and regulatory agencies. Registrants should consult with counsel and their Human Resources departments in deciding whether to provide this information.

Management 40

Management Consulting Provider Physicals 40

FDA Law

MAY 7, 2025

The Seventh Circuit unanimously reversed Sorensens criminal AKS conviction, finding there was insufficient evidence that any of the commissions-based marketing entities leveraged any sort of informal power and influence over healthcare decisions.

Referral 59

Referral Relationship Government Healthcare 59

GeriPal

JULY 19, 2024

What should we use to screen individuals? And either of those could be given to the patient or an informant. Anna 43:15 I mean, yeah, as I’ve had, I think in general, primary care doesn’t have a lot of information about how to use these things. Who should get it if anyone? What happens after they test positive?

Screening 120

Screening Primary Care Patient-Centered IT 120

GeriPal

MAY 11, 2023

It’s just another example of, I think, that there’s a little extra special sauce there in the Beeson program. There’s not that much information on smoking and cognition. I’m thinking of chronic pain, for example, and individuals with chronic pain often have disturbed sleep or other conditions.

Physicals 86

Physicals IT Hypertension Education 86

Medical Xpress

JUNE 16, 2025

More information: ScienceDirect has more on ibogaine. Journal information: Nature Medicine © 2025 HealthDay. The content is provided for information purposes only. However, we do not guarantee individual replies due to the high volume of messages. All rights reserved. Your feedback is important to us.

Mental Health 52

Mental Health IT Medical Specialization 52

GeriPal

FEBRUARY 20, 2025

Thats my main take-home point after learning from our three guests today when talking about trauma-informed care, an approach that highlights key principles including safety, trustworthiness, peer support, collaboration, empowerment, and cultural sensitivity. Eric 00:15 And we have three guests to help us talk about trauma informed care.

Patient-Centered 67

Patient-Centered IT Individual Screening 67

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. However, we do not guarantee individual replies due to the high volume of messages.

Provider 109

Provider Complication Medical Diabetes 109

The Motivated MD

SEPTEMBER 19, 2024

For the better half of 2024, I have been periodically writing posts that are individual articles that double as potential chapters to a future book. Before we discuss each individual savings account, let us first highlight exactly what it means to ‘automate’ your savings. Saving money is simple but not easy.

Finance 52

Finance Individual Education Healthcare Professional 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. The foundational literature in this area has furthered stigma and bias, especially towards Black birthing persons.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

ABIM

JUNE 11, 2025

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

Board-Certified 52

Board-Certified Government Community Education 52

GeriPal

AUGUST 29, 2024

We must often deliver complex medical information that carries heavy emotional weight in pressured settings to individuals with varying cultural backgrounds, values, and beliefs. And one of the hardest things is to distill it down to a sentence or two about what is information, what does it mean? And then be quiet and listen.

IT 133

IT Illness Family Families 133

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. So my special guest host on this episode is a trainee in pediatrics and medical genetics. I put a lot more information about Dr. Groopman and how to contact her in the show notes.

Consulting 59

Consulting Individual Family Families 59

GeriPal

MAY 25, 2023

Sarah: Yeah I similarly feel like, you know, focusing more on the process, the qualitative kind of from a research standpoint, the qualitative information that we’re getting from folks. Hillary or Sarah. Thoughts on that. I think all three of us are probably ready to answer that to some extent.

Community 96

Community IT Patient-Centered Primary Care 96

GeriPal

OCTOBER 17, 2024

We talk about what is heart failure, particularly HFpEF, how we treat it (including the use of sodium–glucose cotransporter-2 inhibitors (SGLT2’s), and how we should apply guidelines to individual patients, especially those with multimorbidity who are taking a lot of other medications. Because I think we have someone special, a guest host.

Primary Care 114

Primary Care Patient-Centered IT Patients 114

GeriPal

JANUARY 25, 2024

It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. I’d be operating at the top of what I’m capable of doing, to provide really tailored and individualized care for my patients and their care partners, where they are.

Patient-Centered 123

Patient-Centered IT Illness Patients 123

Plum Health

OCTOBER 16, 2024

Whether you need a routine physical, vaccination, or management of a chronic illness, this clinic has you covered with a focus on holistic and individualized care. Primary Care for All Ages and Stages of Life This clinic specializes in primary care for patients of all ages. The clinic in Royal Oak is perfect for my whole family.

Clinic 52

Clinic Chronic Disease Management Primary Care Medical 52

GeriPal

FEBRUARY 29, 2024

It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. Anne: Well, speaking of your kids, a very special, sometimes listener, chimed in named Ren Smith. ABIM MOC credit will be offered to subscribers in November, 2024. Alex: Okay. Alex: Yeah.

IT 127

IT Patient-Centered Illness Education 127

GeriPal

APRIL 4, 2024

Arguing for the state of Missouri against the Cruzan’s was Ken Starr, who would later be assigned the role of special prosecutor in the investigation of the Clintons (Whitewater, Lewensky, etc). It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Family 113

Family Families Patient-Centered IT 113

GeriPal

JULY 28, 2022

Alex: And we are also delighted to welcome Areej El-Jawahri, who is an oncologist at Massachusetts General Hospital as well, who specializes in blood cancers. So I really opted to specialize in lung cancer because I thought that was the appropriate population to build a supportive and palliative care research agenda. Jennifer: Thanks.

Illness 111

Illness Hospital Patient-Centered Patients 111

PEMBlog

JANUARY 16, 2025

As always, Im your host, Brad Sobolewski, and today were diving into an important topic, inhalant misuse, with a special focus on nitrous oxide. You can either get one little individual canister of nitrous, or a big canister which costs about 120 to 120. Further complicating matters is that each inhalant has its own special risks.

Complication 52

Complication Patient-Centered Management Patients 52

GeriPal

SEPTEMBER 22, 2022

One bump is just the classic pitfalls we often talk about in serious illness communication: being very jargony, very information focused, and just providing information. All these studies in this fringe… We want the special key. And oftentimes the existential landscape of serious illness, there’s no special thing.

Illness 102

Illness IT Patient-Centered Patients 102