The Clinical Problem Solvers

MAY 20, 2020

Marc Heincelman Marc Heincelman is an assistant professor within the Department of Medicine at the Medical University of South Carolina, where he also serves as director of the Medicine Clerkship and Acting Internship.

Clinic 52

Clinic Internal Medicine Diagnosis Illness 52

FDA Law Blog

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. products intended for medical purposes). products intended for medical purposes).

Medical 98

Medical Manufacturing Healthcare Government 98

The Clinical Problem Solvers

MARCH 10, 2021

After completing medical school at Texas Tech University, she moved up to North Carolina for residency. From there, she came to Chapel Hill for medical school and stayed at UNC for residency training. Ann Marie Kumfer & Dr. Debra Bynum Want to test your learning? Want to learn more about the Women in Diagnosis (WDx) series?

Clinic 52

Clinic Internal Medicine Diagnosis Appointment 52

Annals of Family Medicine

NOVEMBER 20, 2024

Setting or Dataset: Data encompassed awards from various federal agencies, predominantly including the US National Institutes of Health and others from 2014-2023. Population Studied: US DFMs Intervention/Instrument: The NIH RePORTER and Liaison Committee on Medical Education (LCME) databases.

DO 130

DO Family Medicine Family Families 130

Annals of Family Medicine

NOVEMBER 20, 2024

Setting or Dataset: Electronic health records data: 335 CHC from the ADVANCE research Network Population Studied: Adults (n=309,074) aged 19-64 patients with a baseline insured visit between 2014 and 2019 and at least 3 ambulatory visits over the subsequent 3-year period and at least 12 months separating the first and last visits.

Patient-Centered 130

Patient-Centered Insurance Diabetes Community 130

Myriad Genetics

MAY 20, 2025

The majority of these patients (54%) agree that genetic testing for mental health medications (known as pharmacogenomic or PGx testing) could reduce these concerns. The majority of these patients (54%) agree that genetic testing for mental health medications (known as pharmacogenomic or PGx testing) could reduce these concerns.

Mental Health 52

Mental Health Diagnose Medical Patients 52

Medical Xpress

JANUARY 20, 2023

The national uninsurance rate for adults under age 65 with schizophrenia decreased by 50% after the implementation of the Affordable Care Act (ACA) in 2014, according to University of Massachusetts Amherst research published this week in JAMA Psychiatry.

Insurance 98

Insurance 98

FDA Law Blog

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. products intended for medical purposes). products intended for medical purposes).

Medical 75

Medical Manufacturing Healthcare Government 75

Medical Xpress

FEBRUARY 22, 2023

in 2014—represent a class of infectious agents in beef and cow's milk that have been linked to the development of cancer. Bovine meat and milk factors (BMMFs)—initially identified by de Villiers et al.

Individual 98

Individual 98

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. 2018 Nov 22;379(21):2002-2014. Parents often use probiotics, like Lactobacillus rhamnosus GG , hoping to reduce the severity of their child’s gastroenteritis. N Engl J Med.

Hospital 105

Hospital Illness Patients Provider 105

The Clinical Problem Solvers

JANUARY 18, 2021

Published June 10, 2014. Harvard Medical School Primary Care Blog. Creating a segregated medical profession: African American physicians and organized medicine, 1846-1910. Medical Care. A Historic Day For Black Women, A Historic Day For The American Medical Association. American Medical Association.

Community 52

Community Medical Individual IT 52

Adventures of a Sick Doctor

JULY 4, 2024

This had been preceded by a fantastic 24 hours in Madrid with another raft of fabulous females, which had come just after the Medical Women's Federation conference in Cambridge where I met loads of lovely people. I was just back from a gorgeous few days walking a teeny tiny bit of the Camino de Santiago in Spain with two mighty women.

GP 100

GP Families Family IT 100

The Direct Doctors Difference

AUGUST 18, 2021

Looking back to 2014, when we began, there were less than 100. A system more balanced by small practices mixed into larger hospitals will bring us back to a time when patients and doctors were happier with care and corporations didn’t dictate medical choice. There are likely many more than have been officially labeled on the map.

Primary Care 52

Primary Care Healthcare Insurance Government 52

Medical Xpress

JANUARY 3, 2023

In total, massive amounts of data from around 45 million hospitalizations and 7,239,710 patients in Austria between 2003 and 2014 were studied.

Diabetes 64

Diabetes Hospital Patients 64

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

The Clinical Problem Solvers

JUNE 12, 2022

His past medical history is significant for hypertension and diabetes mellitus. Developing Medical Educators of the 21st Century, San Francisco, CA. 2018;33(11):2010-2014. One day later the patient also develops a rash. At this time, you might want to activate another schema, for example, “Fever + Rash”. Custers, Steven J.

Diagnosis 52

Diagnosis Illness Clinic Diabetes 52

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

Adventures of a Sick Doctor

NOVEMBER 7, 2020

The reason for my restricted movements was my Portacath, the small firm hockey-puck device which was implanted in the right side of my chest wall in December 2014. and I say “very little” (knowing from years of medical school that nothing is ever 0%). This piece was first published in the Medical Independent] should suffice.

IT 100

IT Medical Hospital 100

FDA Law Blog

JANUARY 12, 2025

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

Clinic 64

Clinic Relationship Provider IT 64

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. Background FDA first introduced the final rule and guidance on eMDR in 2014 , which we blogged about here.

Electronics 59

Electronics Manufacturing Provider Medical 59

BMJ

JULY 17, 2020

7 Moreover, medical professionals, health practitioners, and relevant academic institutions should proactively disseminate creditable news and information during such health outbreaks through mainstream social media channels. 2014 (28 August). Front Commun ́2020 (June 12; published online). doi:10.3389/fcomm.2020.00039

Community 40

Community Individual Physicals Finance 40

FDA Law Blog

AUGUST 12, 2024

As with other FDA-regulated products, such as human drugs and medical devices, the “regulatory review period” is composed of a “testing phase” and a “review phase.” In February 2010, an oral formulation of BRAVECTO, a medication to treat and prevent fleas and tick infestation in dogs, was the subject of an INAD submitted to the Agency.

Provider 59

Provider IT Consulting Medical 59

AMMD

FEBRUARY 14, 2025

My first breast cancer scare was in 2014, when they discovered calcifications for the first time during a routine mammogram. For this reason, medical experts classify DCIS as noninvasive. Medical experts also call these calcifications. In fact, I had a similar situation happen to me not too long ago. What Causes DCIS?

Diagnosis 130

Diagnosis Screening IT Patient-Centered 130

FDA Law Blog

JUNE 29, 2022

In May 2014, FDA finalized a guidance document entitled “ Expedited Programs for Serious Conditions – Drugs and Biologics ,” (the Expedited Programs Guidance) This guidance noted that a “[d]esignation may be rescinded if it no longer meets the qualifying criteria for breakthrough therapy.” Granted . Rescinded .

IT 52

IT Clinic Provider Medical 52

FDA Law Blog

SEPTEMBER 13, 2022

Lenz, Principal Medical Device Regulation Expert — It’s been almost 11 years since FDA first clarified use of multiple predicate devices and introduced the concept of Reference Devices in the draft guidance titled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], which we blogged about here.

IT 52

IT Medical Provider 52

PEMBlog

SEPTEMBER 23, 2024

Andrea De Jesús Martínez Chief PEM Fellow at Baylor College of Medicine | Texas Children’s Hospital Instagram: @bcm_pemfellows Co-author: Benjamin Silva, MD, MPH The Case A 4-year-old male with no significant past medical history presents with headache and vomiting. 9,3 (2014): 168-72. At that visit, his physical exam was normal.

Diagnosis 59

Diagnosis Physicals Hypertension Families 59

FDA Law Blog

MAY 7, 2025

Gonzalez There has been increased enforcement against medical device companies that engage in the pervasive practice of paying third party sales agents based on their volume of sales. In that decision, a medical laboratory paid Marchetti percentage-based compensation for successful referrals of Medicare patients to the laboratory.

Referral 59

Referral Relationship Government Healthcare 59

FDA Law Blog

JANUARY 30, 2025

For instance, the December 2024 guidance goes beyond the 2014 Expedited Programs for Serious Conditions Drugs and Biologics guidance (the last to deal substantively with accelerated approval) to describe FDAs expectation that sponsors take a proactive approach to ensuring confirmatory trials are completed within specified timelines.

IT 105

IT Clinic Provider Patients 105

FDA Law Blog

OCTOBER 14, 2024

2014); U.S. HTC/Ps in this last category are regulated as drugs or medical devices under the FDCA, or biological products under section 351 of the PHSA, which typically require premarket approval and compliance with the full panoply of FDA regulation. Regenerative Sciences, LLC , 741 F.3d 3d 1314 (D.C. Stem Cell Clinic, LLC , 998 F.3d

Clinic 59

Clinic Patient-Centered Asthma Patients 59

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. 25, 2014). When a Patient Speaks (Sept.

Patients 52

Patients Patient-Centered Clinic IT 52

FDA Law Blog

DECEMBER 11, 2023

6] It is inconsistent to say that LDTs must be regulated as medical devices because of the newness of the tests and then reduce the cost of the proposed regulation by declaring that half of all LDTs will be exempt from premarket review. 2, 2014), [link]. [12] 2, 2014), [link]. [12] 31, 2023), [link]. [10] 11] Jeffrey N.

IT 69

IT Medical Patient-Centered Provider 69

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.

Clinic 59

Clinic IT Provider Patient-Centered 59

FDA Law Blog

FEBRUARY 27, 2024

In September 2014—nearly ten years ago!—PTE But there are still a couple of possibilities lurking out there! The first multiple PTE case up-to-bat concerns Gilead Sciences Inc.’s The first multiple PTE case up-to-bat concerns Gilead Sciences Inc.’s PTE applications were submitted to FDA for each of U.S. RE 44,599 and U.S.

Patients 59

Patients IT Provider Individual 59

FDA Law Blog

JUNE 14, 2022

Though Esai’s Fycompa was initially approved in October 2012, it wasn’t scheduled until January 2014, meaning that Esai lost a little more than a year of patent life awaiting scheduling—in addition to the time spent in regulatory development and review.

IT 52

IT Provider Medical 52

Pamela Wible MD

JUNE 20, 2025

(Published 3/18/19, updated 6/20/25) What Is Physician “Burnout”—and Why It Matters Physician “burnout” is a state of emotional, physical, and mental exhaustion caused by prolonged stress in the medical workplace. and it has been linked to rising rates of physician depression , doctor suicide , and medical errors.

Medical Student 246

Medical Student Diagnosis Physicals Medical 246

Annals of Family Medicine

NOVEMBER 20, 2024

Dataset: Quebec administrative health databases containing de-identified prescription drug claims, ER visits, hospitalizations, and medical acts held by the National Institute for Excellence in Health and Social Services (INESSS) were used. Outcome measures: 1) yearly prevalence and incidence of exposure to at least one high-priority DDI.

Primary Care 130

Primary Care Emergency Room Insurance ER 130

GeriPal

OCTOBER 24, 2024

David is a physician who wrote the book “ Stoned: A Doctor’s Case for Medical Marijuana ” and gave a TED talk on “ A Doctor’s Case for Medical Marijuana ” that was watched over 3 million times. laughter] Alex 01:39 Material here for songs related to medical marijuana or marijuana in general. Eric 01:34 Yeah.

Medical 100

Medical IT Patient-Centered Healthcare 100