Doctor Rachel

MARCH 14, 2017

My sister Lisa, who is a 30-year veteran educator who specializes in anxious teens, suggests that creating an environment in which young people can feel safe, form connections with other young people, and be successful, is the key to helping them recover their peace of mind. And I am not alone.

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FDA Law

AUGUST 23, 2021

These revisions appear to be responsive to a November 16, 2020 Special Fraud Alert issued by the Office of Inspector General at the U.S. Department of Health and Human Services (OIG) (see our blog post on this Special Fraud Alert here ). not friends, significant others, or family members of a speaker or invitee).

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Specialization Manufacturing Education Provider 52

The Clinical Problem Solvers

SEPTEMBER 19, 2024

Cooper September 19, 2024 Summary : This episode highlights a selection of antiracism research presentations at a live recording of the podcast at the 2024 SGIM Annual Meeting. During this episode, we hear from Dr. During this episode, we hear from Dr. S. She has advanced training in Quality Improvement and Patient Safety Science.

Internal Medicine 52

Internal Medicine Patient-Centered Specialization Community 52

Physician's Weekly

JUNE 25, 2025

Giant cell arteritis is one of the most common when we see it, particularly when it presents with signs and symptoms of head and neck ischemia. Hello, it’s great to be with you. I am Dr. Adam Killian. I am a rheumatologist and the director of the rheumatology fellowship training program at St. Louis University.

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Management Diagnosis Patient-Centered Patients 59

FDA Law

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. This lawsuit was brought to the U.S. district court of Massachusetts by former employee and whistleblower Michael Bawduniak in April 2012 as a qui tam action.

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Consulting Healthcare Professional Specialization Government 105

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).

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Barton Associates

JUNE 19, 2025

Doing so builds your reputation in the community as a trusted source of excellent care, but relying solely on permanent staff can present challenges in maintaining this standard. As a healthcare facility, your primary focus is on consistently providing the highest-quality services possible to your patients.

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Healthcare Healthcare Professional Provider Community 52

Imperial Center Family Medicine

APRIL 14, 2025

Accommodate Special Considerations Certain groups are particularly at risk for early heart disease tied to high cholesterol. Finding problems before they compound makes accommodating special considerations, including possible statin use, much more impactful. Healthy living’s preventive payoff gets bigger the earlier it starts.

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Screening DO Family Medicine Family 52

FDA Law

NOVEMBER 6, 2024

Starting in 2022 with a patent certification requirement, both Jazz and Avadel have sued FDA over this drug, with Jazz most recently bringing suit challenging FDA’s decision that Avadel’s Lumryz (sodium oxybate) is clinically superior to Jazz’s Xywav (sodium oxybate) in 2023. This case followed. The Court held that it does.

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Clinic IT Patient-Centered Consulting 111

Louisville Lectures

OCTOBER 5, 2018

Other Series: Pulmonary & Critical Care These lectures focus on pulmonary and critical care themes and are presented by our esteemed faculty and fellows from the University of Louisville Division of Pulmonary, Critical Care and Sleep Medicine. I am so grateful to have access to these lectures.they have been a lifesaver.

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Internal Medicine Medical Student Education Specialization 52

The Clinical Problem Solvers

JUNE 9, 2021

[link] Summary In this special episode of the Antiracism in Medicine Series, originally recorded for the 2021 Society of General Internal Medicine Annual Meeting, the CPSolvers Antiracism team discusses what must be done to make medical education more antiracist. Front Public Health. doi: 10.3389/fpubh.2021.653643

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Education Medical Community Patient-Centered 52

StorytellERdoc

APRIL 11, 2014

After seeing it time and again with every memory of every swing I've ever screamed from, I began to think of what the kick ditch represents to me--of the many things that are present in my life that I did not give the proper attention. Yet, that little ditch kept my momentum going always, even allowing me push off to gain higher altitude.

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Specialization Family Families Transportation 100

Vascular Physician

MARCH 6, 2023

They are essentially hollow tubes with thin walls and special flaps inside them called valves. Symptoms of Venous Diseases As with many other cardiovascular diseases, venous diseases can present a wide range of symptoms depending on the type of disease and the person who has it. What is Venous Disease?

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Transportation Diagnose Management Appointment 52

FDA Law

OCTOBER 24, 2023

The SIUU Guidance introduces two new concepts that are of note to industry regarding information it may choose to disseminate under this “safe harbor:” 1) application to firm-generated presentations of scientific information; and 2) material that meets a new evidentiary standard – scientifically sound and clinically relevant.

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Clinic Clinical Practice Provider Utilities 64

FDA Law

SEPTEMBER 30, 2022

Yet, in our view, Dr. Dunn’s opening presentation at the September 7 th Advisory Committee meeting is FDA’s most eloquent description of how to apply appropriate regulatory “flexibility,” which we know can be like asking regulators to color outside of the lines. By Frank J. Sasinowski & James E.

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Community Provider Patients Specialization 98

FDA Law

NOVEMBER 5, 2023

This prestigious four-day conference promises to deliver a wealth of cutting-edge insights, featuring presentations by eminent scientists and clinicians, all unified under the thought-provoking theme, “Towards Better Speech Perception and Beyond.” The comprehensive agenda for the symposium can be accessed in its entirety here.

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Engineering Specialization Community Medical 52

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. abnormal thyroid exam Messaging for patients and families When constipation leads to a child not being able to move their bowels, they may experience pain.

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Diagnosis Diagnose Hospital Clinic 122

FDA Law

OCTOBER 31, 2022

FDA notes that “a future approach could build on features of the current regulatory system, where a Quality Management System and other general and, in some cases, special controls provide a reasonable assurance of safety and effectiveness for certain low to moderate risk devices.” As part of the pilot program, FDA included a Test Plan.

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Manufacturing Specialization Management IT 72

The Motivated MD

OCTOBER 10, 2024

If you scour the internet, you will likely find an inordinate amount of websites and content creators claiming they have the solution to help you beat the market, guaranteed. These claims are, of course, bogus. No one can consistently beat the market; for the incredibly rare few who do, it is either luck or fraud. Though being 100% invested in U.S.

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Finance Individual Management IT 52

GeriPal

MAY 19, 2022

Summary Transcript Summary. A patient is on morphine and you want to convert it to another opioid like hydromorphone (dilaudid). How do you do that? Do you do what I do, pull out a handy-dandy opioid equianalgesic table to give you a guide on how much to convert to? . which advocates for an updated, wait for it… equianalgesic table! . Drew: Yeah.

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Aspiring Minority Doctor

MARCH 26, 2021

It is with great happiness and exhilaration that I announce I finally matched! Even better, I matched into an INTEGRATED PLASTIC AND RECONSTRUCTIVE SURGERY RESIDENCY PROGRAM in MIAMI!!!! Both posts took place after the initial application submission in October, and then life got busy and I didn't write anything else.

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IT Families Family Electronics 52

FDA Law

JULY 26, 2021

A distinguished cast of presenters will share their knowledge and provide critical insights on a host of topics, including (conference agenda here ): The organization, jurisdiction, functions, and operations of FDA. As such, we can offer our readers a special 10% discount. Labeling in the drug and biologics approval process.

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Specialization Provider Management Clinic 52

GeriPal

JULY 19, 2024

Summary Transcript Summary The US Preventive Services Task Force (USPSTF) concluded back in 2000 that there is insufficient evidence to recommend for or against routine screening for dementia in older adults. Are there, though, populations that it may be helpful in, or should that change with the advent of the new amyloid antibodies? Should it?

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Screening Primary Care Patient-Centered IT 119

Reflections of a Grady Doctor

JUNE 30, 2022

What if he was so present, so loving, so engaged, so proud, and so over-the-top supportive that you had nothing—I mean not one single thing—to wish he’d done for you? One distinctly different and special from the one you had with him as a child—and unique to you and no one else? William Ralph Draper, Sr. Rest in power, sweet daddy.

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IT Relationship Specialization Physicals 52

FDA Law

SEPTEMBER 22, 2022

The drug and medical device industries present particularly compelling arenas in which to pursue deterrence through such prosecution because misconduct can carry high levels of public risk. Our own reactions to the decision when it came out was somewhat muted, given that we were in our low single digits at the time of the decision.

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Private Practice Government Individual Specialization 59

FDA Law

JULY 10, 2023

We will then present an effective strategy to address FDA’s AI request in a timely manner. Understanding the Traditional 510(k) Review Timeline There are three types of Premarket Notification 510(k)s: Traditional , Special , and Abbreviated. By Philip Won & Adrienne R. But that is only the beginning.

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Provider IT Engineering Medical 75

The Clinical Problem Solvers

DECEMBER 16, 2020

Tsai has seen race-based medicine play out in clinical practice 10:45 What role should race play in making clinical decisions? 13:16 Status of the current conversation on removing race from eGFR calculators: why is it so contentious? Poet Marge Piercy has written, “The work of the world is as common as mud.”

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Clinic Education Clinical Practice Patient-Centered 52

PEMBlog

MAY 17, 2023

Most children who present to Pediatric Emergency Departments these days with mental health concerns – including agitation – have a known psychiatric problem or diagnosis. Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together.

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Patient-Centered Mental Health Management Finance 68

FDA Law

JANUARY 4, 2024

Faget, Partner, Foley & Lardner LLP and Amy Repolgle, Director, Rx-to-OTC Switch, Bayer will present a must-attend panel focusing on: FDA’s recent efforts to enhance accessibility to OTC drug products that has set the stage for a wave of approved switches in the industry — a development being warmly embraced by non-prescription drug companies.

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Private Practice Specialization Government Management 52

FDA Law

JUNE 28, 2021

On June 26, 2021, during the Minnesota legislature’s special session, the Minnesota House of Representatives passed HF33, an omnibus health and human services bill. The companion bill was already passed by the Minnesota Senate and has a presentment date of today, June 28, 2021.

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Hospital Manufacturing Specialization Medical 52

FDA Law

FEBRUARY 22, 2023

For example, the agency has not offered how many 510(k) submission currently require HF data, the adverse effects of not applying it more widely, and how many submissions would now present HF validation data after the change goes into effect. as a de novo special control or in a guidance document for a specific device type).

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Manufacturing Engineering Medical IT 64

FDA Law

MAY 8, 2023

Further, the MP should address how version information will be presented to the user for the modified device. See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a) a) , and related guidance documents (e.g., here for a 510(k) device and here for a PMA device).

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FDA Law

DECEMBER 7, 2023

There were too many interesting panels and discussions to mention them all, but presentations about DOJ’s and FDA’s coordination deserve some special mention. Gonzalez — The annual Enforcement, Litigation, and Compliance Conference put on by the Food and Drug Law Institute (“FDLI”) took place in Washington this week.

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Consulting Provider Manufacturing Specialization 52

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. As many as 40% of these children will receive a chest x-ray (CXR) during their ED visit despite clinical guidelines advising most of these tests are low value.

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Asthma Electronics Utilities Clinical Practice 52

FDA Law

OCTOBER 25, 2021

Specifically, for 510(k)s, QSR inspections are prohibited unless FDA finds that “there is a substantial likelihood that the failure to comply with such regulations will potentially present a serious risk to human health.” befitted a very important pathway to market for novel medical devices. The new rule will be codified in 21 C.F.R.

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Manufacturing Specialization Government IT 52

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. And because we can’t resist, we dip into aducanumab and lecanemab at the end. AlexSmithMD Transcript Eric: Welcome to the GeriPal Podcast. Kristine, do you have a song request for Alex? Kristine: Yeah, yeah, yeah.

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Physicals IT Hypertension Education 85

PEMBlog

AUGUST 20, 2024

eCPR is typically performed in specialized centers with highly trained personnel in well coordinated teams. It’s much more logistically difficult when the patient arrests out of the hospital and then presents to the emergency department with CPR ongoing via EMS personnel and then to get transitioned to ECMO.

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