Imperial Center Family Medicine

APRIL 14, 2025

Know Your Baseline Your first cholesterol screening in your 20s or 30s provides a baseline for future test results. Accommodate Special Considerations Certain groups are particularly at risk for early heart disease tied to high cholesterol. Statins may plausibly provide greater preventive impact the earlier they are started.

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Screening Family Medicine DO Families 52

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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AMMD

APRIL 4, 2025

They also don’t provide the prebiotics your gut needs to thrive. One way is to breathe into a special balloon. Your doctor can then measure the amounts of gases present. My SIBO Support Protocol provides a strategic combination of supplements and resources designed to rebalance the gut naturally.

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IT Diagnosis Community Chronic Disease 130

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. These lectures will be provided by the University of Louisville Internal Medicine residents.

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Internal Medicine Medical Student Education Specialization 52

FDA Law

NOVEMBER 20, 2024

The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting. FDA is extending the comment period on the notice published September 20, 2024 ( 89 FR 77162 ).

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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

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. due to being historically-controlled) can still be considered an A&WC study.

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FDA Law

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).

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Clinic Clinical Practice Provider Utilities 64

FDA Law

NOVEMBER 6, 2024

Accordingly, FDA “provided a rational explanation of the differences between ordinary brief arousals and a prolonged sleep disruption caused by a second dosing of medication.”

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Clinic IT Patient-Centered Consulting 111

FDA Law

JULY 26, 2021

The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law. Karst will present at a session titled “Hatch-Waxman and BPCIA Fundamentals: Understanding Follow-On Products and the Rules for Generic Entry.”. As such, we can offer our readers a special 10% discount.

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FDA Law

MARCH 6, 2024

His presentation will focus on “MoCRA is Here – Now What? Charles assists clients across a range of FDA-related regulatory matters by providing timely strategic advice on new drug and biologic development and helping them tackle complex regulatory issues. We can offer our readers a special discount for the event.

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Management Manufacturing Government Specialization 59

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.” Key Findings at 12. Streamlined Review.

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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. Emergency provider use of plain radiographs in the evaluation of pediatric constipation. J Pediatr Gastroenterol Nutr. 2014;58(2):258-274. PMID: 24345831. Pediatr Emerg Care.

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Diagnosis Diagnose Hospital Clinic 122

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. Table 1 below shows the 510(k) submission process based on the MDUFA III Performance Goals.

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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.

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Asthma Electronics Utilities Clinical Practice 52

FDA Law

JANUARY 4, 2024

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution. Deb along with fellow panelists Kyle Y.

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Private Practice Government Specialization Management 52

FDA Law

MAY 8, 2023

FDA recommends that PCCPs specify only a “limited number” of modifications but does not provide a limit on the number of modifications that can be included. If the proposed performance evaluation methods are different from the original methods used, the manufacturer should describe the differences and provide a justification for the changes.

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PEMBlog

OCTOBER 18, 2024

Duchenne Muscular Dystrophy (DMD) is a complex and progressive disease requiring highly specialized care, especially in emergency situations. When patients with DMD present in the Emergency Department (ED), an understanding of the nuanced aspects of their care is essential for optimal management.

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Patients Complication Management Consulting 52

The Motivated MD

OCTOBER 10, 2024

So, with this chapter, I hope to briefly touch on the basics of market investing and describe why simple diversification and index fund investing are the most effective ways for busy clinical physicians and healthcare providers to invest with the expectation of long-term gains. Don’t try to beat the market; be the market.

Finance 52

Finance Individual Management IT 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. If enacted, Article 5, Section 6 of HF33 would provide for a reduction to the State’s opiate product registration fee.

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Hospital Manufacturing Specialization Medical 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?

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Screening Primary Care Patient-Centered IT 119

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. In his conference keynote address , Arun Rao—the Deputy Assistant Attorney General for DOJ’s Consumer Protection Branch—provided an overview of DOJ’s year in FDA enforcement.

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Consulting Manufacturing Provider Government 52

FDA Law

FEBRUARY 22, 2023

And HF‑related AI requests are especially nerve‑racking to manage, because of the ever‑present threat that the study must be repeated to adequately respond. as a de novo special control or in a guidance document for a specific device type). Industry would certainly welcome guidance intended to smooth the HF aspects of 510(k) reviews.

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Manufacturing Engineering Medical IT 64

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.” FDCA § 513(f)(5).

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Manufacturing Government Specialization IT 52

The Clinical Problem Solvers

DECEMBER 16, 2020

Use of Risk Assessment Tools to Guide Decision-Making in the Primary Prevention of Atherosclerotic Cardiovascular Disease: A Special Report From the American Heart Association and American College of Cardiology [published correction appears in J Am Coll Cardiol. N Engl J Med. 2010;363(7):609-619. 2019 Jun 25;73(24):3234]. J Am Coll Cardiol.

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Clinic Education Clinical Practice Patient-Centered 52

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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Patient-Centered Hospital Patients IT 52

FDA Law

FEBRUARY 28, 2023

The eSTAR templates are interactive PDF forms used to develop and submit 510(k)s (Traditional, Special, or Abbreviated) or De Novo applications, or to submit additional information to these submission types. There are additionally places to provide attachments for test reports and other supporting documents. New Labeling Requirements.

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FDA Law

MAY 20, 2021

We are providing a post in three parts on cyclic and on-site inspections in which we focus on the background of inspections, how investigators conduct them, and how registrants should proactively prepare for and manage them. The investigators select the drugs they will audit.

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FDA Law

MAY 20, 2021

We are providing a post in three parts on cyclic and on-site inspections in which we focus on the background of inspections, how investigators conduct them, and how registrants should proactively prepare for and manage them. The investigators select the drugs they will audit.

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Management Consulting Provider Physicals 40

FDA Law

JUNE 7, 2023

Doing business with the federal government comes with numerous restrictions and special provisions in exchange for the benefit of having access to Federal reimbursements. In this case, the Supreme Court provided greater clarity on how to interpret that requirement.

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Government Patient-Centered Manufacturing IT 40

Mesa Family Physician

MARCH 13, 2025

Regular visits to your primary care physician at Mesa Family Physicians provide opportunities for early detection of potential health issues before they become serious problems. Arizona’s climate and lifestyle present specific health considerations that our Mesa-based medical professionals are specially trained to address.

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Dr. Michael Bazel

AUGUST 8, 2024

There’s no bacterial infection present in urine tests. Specialized Testing for STIs or IC: If an infection is not found, further tests may be necessary to diagnose underlying conditions like STIs or interstitial cystitis. Unlike a UTI, IC is not caused by bacteria and doesn’t respond to antibiotics.

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IT Complication Medical Advice Chronic Condition 130

Mere Mortal MD

JUNE 5, 2025

I even thought at one point that I would want to become an oncologist, a physician that specializes in taking care of patients with cancer. Answering questions as best I can, and providing support for the understandable fear that comes with disease and cancer and death. It’s when I feel like I make the most difference.

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Patient-Centered Medical Patients IT 130

ABIM

JUNE 4, 2025

See the discussion on the Special Consideration IMG (International Medical Graduates) Pilot Pathway below.) Dr. McDonald spoke about ABIM’s work engaging early career physicians (those who earned initial certification within the last 10 years), including presentations and listening sessions at recent national meetings.

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The Clinical Problem Solvers

FEBRUARY 8, 2023

Together, our guests explore and unpack how the criminalization and racialization of substance use builds to the present-day opioid epidemic and shapes inequities in care. A more Western perspective on health care emphasizes the role of physicians and health care providers and marginalizes the role and contributions of doulas and midwives.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

Georgetown Pediatrics & Family Medicine

FEBRUARY 7, 2022

From The Children’s Foundation : In celebration of Black History Month, we are reflecting and honoring the contributions Black leaders have made toward the advancement of equality and improvement of children’s health and wellness, both historically and in the present day.

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Mental Health Patient-Centered Hospital Education 40

ABIM

MAY 30, 2025

The Nephrology Board does not currently have a member who is a private practice general nephrologist and agreed to give special consideration to applicants from non-university, community settings for the next opening that will occur in July 2026. Get in Touch ABIM and the Nephrology Board value your feedback.

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