Louisville Lectures

NOVEMBER 21, 2018

During this time, catch up on your Medical Education below… Pulmonary and Critical Care Lecture Series 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. Click here to visit.

Internal Medicine 52

Internal Medicine Education Clinic Provider 52

The Clinical Problem Solvers

SEPTEMBER 19, 2024

Michelle Ogunwole, MD, PhD, an internist and social epidemiologist who specializes in the care of women with chronic medical conditions and racial disparities in maternal health outcomes, and Dr. Caroline Sloan, MD, a general internist whose research focuses on how financial considerations are imbued into medical decision-making.

Internal Medicine 52

Internal Medicine Patient-Centered Specialization Community 52

Louisville Lectures

OCTOBER 5, 2018

We are excited to help expand the FOAMed movement into internal medicine where so much work has been done by various medical education programs. "I It is a wonderful act of altruism to make them accessible to the public. " - a viewer that recently started a medical position in a country hospital in Australia. Visit here.

Internal Medicine 52

Internal Medicine Medical Student Education Specialization 52

Louisville Lectures

MAY 5, 2023

Are you a resident or medical student looking to learn practical, evidence based approaches to your patients? We believe in the concept of Free Open Access Medical Education ( #FOAMed ) and we focus on internal medicine ( #FOAMIM ). These lectures will be provided by the University of Louisville Internal Medicine residents.

Internal Medicine 52

Internal Medicine Patient-Centered Education Hospital 52

Family Physicians of St. Joseph

SEPTEMBER 25, 2018

Joseph, the family medicine practice is committed to providing exceptional, affordable, patient-centered primary care in SW Michigan without reliance on insurance companies for payment of services. John Proos, with the goal of providing exceptional care to the patients of Berrien County. Joseph, P.C.,

Family Physician 52

Family Physician Families Family Primary Care 52

Physician's Weekly

JUNE 19, 2025

Gowin and his colleagues analyzed data from 1,003 adults between 22 and 36 years of age who had functional magnetic resonance imaging (fMRI), urine toxicology, and cannabis use results collected at one academic site between 2012 and 2015 as part of the Human Connectome Project. The cohort (mean age, 28.7

Community 52

Community Healthcare Diagnosis Medical 52

The Clinical Problem Solvers

JUNE 26, 2023

Episode Learning Objectives After listening to this episode, learners will be able to… Differentiate between stigma and bias in health care and the electronic health record using provided examples. Describe difficulties and examples of how to measure unconscious race bias in medical practice.

Electronics 52

Electronics Internal Medicine Patient-Centered Healthcare 52

PEMBlog

OCTOBER 31, 2024

However, this large study shows that probiotics do not significantly shorten illness duration, improve symptoms, or reduce the need for additional medical visits. Caution While this study provides important insights, it is worth noting that probiotics may still play a role in other health contexts. N Engl J Med 2018; 379:2015-2026.

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Hospital Illness Patients Provider 105

FDA Law Blog

AUGUST 15, 2021

Shapiro — A determination of “intended use” is fundamental to FDA’s regulation of drugs and medical devices. Thus ends a saga that began with a proposal in 2015 to amend the “intended use” regulation. This set off a firestorm, eventually leading to a new proposed rule in 2020, which was much closer to the one in 2015.

Manufacturing 93

Manufacturing IT Provider Government 93

The Clinical Problem Solvers

MARCH 14, 2025

Simon is a pediatric addiction medicine psychiatrist at Boston Children’s Hospital; an assistant professor in psychiatry at Harvard Medical School; a recent Commonwealth Fund fellow in health policy at Harvard University; and the medical director of Wayside Youth & Family Support Network.  Epub 2015 Dec 1. Psychiatr Serv.

Mental Health 52

Mental Health Community Patient-Centered Hospital 52

FDA Law Blog

SEPTEMBER 30, 2022

This approval decision charts a path for the exercise of appropriate flexibility in regulatory decisions for other rare conditions where there is a serious and/or life-threatening unmet medical need, as is very often the case. This is evidence of FDA’s embrace of patient-focused drug development. emphasis added).

Community 98

Community Provider Patients Specialization 98

The Clinical Problem Solvers

APRIL 24, 2025

Simon is a pediatric addiction medicine psychiatrist at Boston Children’s Hospital; an assistant professor in psychiatry at Harvard Medical School; a recent Commonwealth Fund fellow in health policy at Harvard University; and the medical director of Wayside Youth & Family Support Network.  Epub 2015 Dec 1. Psychiatr Serv.

Mental Health 52

Mental Health Community Hospital Appointment 52

FDA Law Blog

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Since the final rule took effect on August 14, 2015, medical device manufacturers and importers have been required to submit MDRs in an electronic format.

Electronics 59

Electronics Manufacturing Provider Medical 59

FDA Law Blog

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

FDA Law Blog

APRIL 11, 2022

Medtronic Warning Letter) provides an important reminder from FDA as to the correct estimation of risk associated with malfunctions. Of course, it would not always be true that there is a significant gap between the number of medical devices shipped and the number in actual use. A December 2021 warning letter to Medtronic, Inc.

Medical 40

Medical Management Manufacturing Patients 40

33 Charts

OCTOBER 2, 2021

The zero-sum medical day In many healthcare systems the Epic feature is turned on and health professionals are expected to respond. The problem is that doctors work in what I call a zero-sum medical day. While this may help the zero-sum medical day on one level, compensation models don’t necessarily fix the problem of human bandwidth.

Patients 75

Patients IT Provider Family Doctor 75

FDA Law Blog

SEPTEMBER 26, 2024

Newberger — We can all acknowledge that the title of this post is not that funny-at least, not to anyone other than medical device regulatory nerds, such as the author of this post. The Breakthrough program started in 2015. By Jennifer D. The reality, however, is quite different.

Clinic 64

Clinic IT Manufacturing Medical 64

Louisville Lectures

OCTOBER 30, 2020

This can be extremely hard to find sometimes – if you cannot find a suitable place at home, contact your medical school/local library to see if they have rooms you can book beforehand. Not only does it help with decreasing feedback noise, but also can provide a “cue” as to when you are about to start/stop talking.

Screening 52

Screening IT Internal Medicine Medical 52

FDA Law Blog

FEBRUARY 29, 2024

As FDA explains on its website (which includes lists— here and here —of the more than 300 Accelerated Approvals (and withdrawals)): The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint. Patent Nos.

Clinic 59

Clinic IT Provider Patient-Centered 59

Physician's Practice

JUNE 25, 2025

These videos are 5 to 10 minutes in length and will provide practical ideas and suggestions that have been tested in his practice or used by other physicians that significantly improve the efficiency and productivity of their medical practices. Dr. Baum was the columnist for American Medical News for more than 25 years.

Patients 52

Patients Private Practice Management Healthcare 52

FDA Law Blog

AUGUST 11, 2024

FDA’s stated concern from a public health perspective is that the omission of risk information “fails to provide material information about the consequences that may result from the use of Auvi-Q and creates a misleading impression about the drug’s safety.” August 2024 Untitled Letter to Mirati Therapeutics Inc.

Clinic 59

Clinic Provider IT Complication 59

FDA Law Blog

MAY 25, 2022

The safety communication acknowledges that the tests “may provide useful information to assess the risk that a fetus has (or does not have) a genetic abnormality.” However, even with a low PPV, a test can provide clinically useful information to providers and patients.

Provider 40

Provider Screening Medical Patients 40

FDA Law Blog

JUNE 23, 2021

As someone who studied in the fields of public health, medical sociology, and biomedical ethics, I was impressed with how quickly the pharmaceutical and biotechnology arena caught up with what took many decades to occur in the context of the physician-patient relationship.

Patients 52

Patients Patient-Centered Clinic Community 52

FDA Law Blog

JUNE 29, 2022

The Expedited Programs Guidance describes situations warranting rescission as when emerging data no longer support the BTD, another product gains traditional approval and evidence is not provided that the designated drug may demonstrate substantial approval over the approved product, or when the program is no longer being pursued.

IT 52

IT Clinic Provider Medical 52

FDA Law Blog

FEBRUARY 27, 2024

For years after the enactment of the Hatch-Waxman Amendments the PTO interpreted the PTE statute to permit multiple PTEs, provided there are separate, but not necessarily different, regulatory review periods. FDA-2015-E-2602, FDA-2015-E-2604, FDA-2015-E-2619, and FDA-2015-E-2615. 351, 355-56 (1985).

Patients 59

Patients IT Provider Individual 59

FDA Law Blog

JANUARY 31, 2022

The United States filed a Complaint against Texas entities Zarzamora Healthcare LLC, Rite-Away Pharmacy and Medical Supply #2– and its Pharmacist-in-Charge (PIC), and part owner. Because Plaintiff has provided no notice to defendants, the Court is precluded from issuing any preliminary injunction. 21 U.S.C. § 21 U.S.C. §

Government 40

Government IT Provider Healthcare 40

FDA Law Blog

FEBRUARY 4, 2022

Richardson — FDA has released its Proposed Rule of National Standards for Third-Party Logistics Providers (“3PLs”) and Prescription Drug Wholesale Distributors (“WDDs”). This seems similar to DEA’s understanding of “coincident” activities of the registrant’s business that do not need a separate registration. 21 U.S.C. §

Supply Chain 40

Supply Chain Manufacturing Provider IT 40

FDA Law Blog

JUNE 14, 2022

And that’s exactly what Esai did back in 2016 when it submitted a supplement to its request for a patent term extension (PTE) asking FDA to revise its “date of approval” calculation for purposes of PTE calculation for its anti-epileptic drug product, Fycompa (perampanel), after Congress passed the “ Improving Regulatory Transparency for New Medical (..)

IT 52

IT Provider Medical 52

Annals of Family Medicine

NOVEMBER 20, 2024

Objective: Identify patient, provider, and healthcare process and utilization factors associated with rates of secondary acceptance of the HPV vaccine. Existing research on secondary acceptance has focused on demographics and initial declination with little evidence around factors associated with increased rates of secondary acceptance.

Vaccination 130

Vaccination Family Medicine DO Primary Care 130

GeriPal

MAY 18, 2023

Summary Transcript Summary Hot off the press is a brand spanking new updated 2023 AGS Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. The Beers Criteria is one of the most frequently cited reference tools in geriatrics, detailing potentially inappropriate medications to prescribe to older people.

Medical 97

Medical IT Patients Clinic 97

Annals of Family Medicine

NOVEMBER 20, 2024

Study Design and Analysis: Mixed-method convergent design, combining quantitative secondary analysis of records from 158 stillbirth and infant deaths reviewed by Kalamazoo County FIMR from 2015 to 2023, and qualitative semi-structured interviews with 26 national FIMR stakeholders. versus 0.8, 01), person-centered decision-making (average 0.5

Families 130

Families Family Utilities Education 130

Physician's Weekly

JUNE 22, 2025

Similarly, listening was rated lower (β = −0.286, 95% CI = −0.391 to −0.181, P = 0.001), as were explanations provided by clinicians (β = −0.133, 95% CI = −0.267 to −0.000, P = 0.050). These outcomes were adjusted for variables including age, race, ethnicity, income, health insurance, educational status, and coexisting medical conditions.

Individual 59

Individual Insurance Education Medical 59

FDA Law Blog

DECEMBER 18, 2022

Mullen — On December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices. FDA began an initial VMSR pilot program in 2015. The draft guidance provides information about the VMSR Program eligibility and scope, reporting conditions, and the reporting process.

Medical 59

Medical Manufacturing Individual Provider 59

GeriPal

MARCH 2, 2023

By 2015 that number increased to 4% of US adults. Eric: Any other interesting tidbits or facts that we should know as providers about gabapentin or Lyrica dosing or pharmacology? It’s not a controlled substance medication. Eric: So I heard gabapentin is the 10th most commonly prescribed medication in the US.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

GeriPal

JUNE 19, 2025

And so when I had decided to socially, medically, and surgically transition, I had to really sit down with members of the department and really did a lot of in services. It was also the time that in 2015, that people who were trans and famous really put being trans on the map at that time, too. Eric 04:53 How is it public?

Individual 82

Individual Community IT Chronic Condition 82

PEMBlog

MAY 15, 2023

Our role as providers is to identify the patients who have a life-threatening etiology to their syncope. Your history and medication reconciliation will assist in determining acquired vs congenital variants. Acquired long QT can be caused by electrolyte disorders, eating disorders and/or medications. Fleisher, Gary R.,

Utilities 97

Utilities Screening Physicals Medical 97

GeriPal

APRIL 13, 2023

Check out some of their recent work, including: Dr. Holt-Lunstad’s and Dr. Perissinotto’s powerful perspective piece in the New England Journal of Medicine which provides a clinical framework for addressing loneliness and social isolation. We’ll talk about is it in medical practice yet? And then the second one in 2015.

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IT Community Patient-Centered Medical 99