California Academy of Family Physicians (CAFP)

MAY 14, 2025

Elimination of (State-Only) Prospective Payment System Rates to Federally Qualified Health Centers and Rural Health Clinics for Undocumented Immigrants – Eliminates Prospective Payment System rates to clinics for state-only-funded services provided to undocumented Individuals. The policy would be effective January 1, 2026.

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Healthcare Family Physician Management Individual 204

The Clinical Problem Solvers

DECEMBER 16, 2020

Nwamaka Eneanya and Jennifer Tsai to discuss the limitations and harms of race-based medicine in clinical practice. Our guests explain how we can incorporate race-conscious medicine in clinical settings, medical education, and biomedical/epidemiological research to responsibly recognize and address the harms of racial inequality.

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Clinic Education Clinical Practice Patient-Centered 52

Louisville Lectures

SEPTEMBER 18, 2020

She then compares and contrasts hunger and food insecurity and describes the scope of the issue in Louisville/Jefferson County as well as in the clinic population. After, Dr. Olges describes the clinical implications of food insecurity and finally, reviews the process for accessing the food bank in the AIM clinic.

Internal Medicine 52

Internal Medicine Hospital Clinic Medical 52

Medical Xpress

FEBRUARY 24, 2023

As legislation in multiple states eases former restrictions around medical and recreational cannabis in the United States, an increasing proportion of the population reports use of the drug. Between 2016 and 2018, more than 22 percent of Massachusetts residents reported any prior cannabis use for medical or recreational reasons.

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Healthcare Patients IT Medical 98

The Medical Futurist

MAY 18, 2025

Assisting surgeries, disinfecting rooms, dispensing medication, keeping company: believe it or not these are the tasks medical robots will soon undertake in hospitals, pharmacies, or your nearest doctor’s office. Instead of a human, however, they used a mannequin designed for medical training.

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The Medical Futurist

JUNE 21, 2025

In 2016, The Guardian reported that a blind woman suffering from this disease was fitted with the implant labelled “bionic eye” in the UK as part of a trial at the Oxford Eye Hospital. However, things are moving fast, and success doesn’t come easy for the pioneers of any medical field. Cyborgization is upon us?

Diabetes 98

Diabetes Patient-Centered IT Patients 98

Louisville Lectures

NOVEMBER 7, 2019

She began her residency in a combined internal medicine and pediatrics program at Vanderbilt University in Nashville, TN and completed her training at Loyola University Medical Center in Maywood, IL. She remained at Loyola University as an Assistant Professor in Hospital Medicine before moving back to Louisville in 2016.

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Internal Medicine Hospital Clinic Medical 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).

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Medical Manufacturing Healthcare Government 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

The Clinical Problem Solvers

APRIL 24, 2025

Dr. Benton mentors clinical and research physicians, fellows, and postdoctoral trainees. Clinically, he cares for youth and families through the Department of Psychiatry & Behavioral Sciences and the new Division of Addiction Medicine at Boston Children’s Hospital. Child and Adolescent Psychiatric Clinics of North America.

Mental Health 52

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The Clinical Problem Solvers

MARCH 14, 2025

Dr. Benton mentors clinical and research physicians, fellows, and postdoctoral trainees. Clinically, he cares for youth and families through the Department of Psychiatry & Behavioral Sciences and the new Division of Addiction Medicine at Boston Children’s Hospital. Child and Adolescent Psychiatric Clinics of North America.

Mental Health 52

Mental Health Community Patient-Centered Hospital 52

FDA Law Blog

NOVEMBER 20, 2024

Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. FDA suggests that simulated use/leachables studies to simulate the clinical use (i.e.,

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Provider Medical Manufacturing Consulting 59

Physician's Weekly

JUNE 24, 2025

So, in 2016, she celebrated her 60th birthday at her local CVS. Robin Wolaner, 71, a retired publisher in Sausalito, California, has been known to badger friends who delay getting recommended shots, sending them relevant medical studies. “I was there when they opened,” Beckham recalled.

Vaccination 52

Vaccination Illness Hospital Patient-Centered 52

FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

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Clinic Medical Provider Patients 52

Tiny Physician

AUGUST 12, 2021

As a person who spent almost a decade at medical colleges, I have heard numerous sexist comments from the faculty regarding the dressing sense of their students. My time at a North Indian medical college didn’t expose the dark side of such oral codes; however, in Kerala, I experienced such medieval customs and traditions.

Medical 52

Medical Medical Student Illness Education 52

PEMBlog

JUNE 14, 2023

This episode is a co-production of the Emergency Medical Services for Children Innovation and Improvement Center whose mission is to minimize morbidity and mortality of acutely ill and injured children across the emergency continuum. Children’s Mental Health Emergency Department Visits: 2007-2016. Government. Pediatrics.

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Mental Health Management Patient-Centered Illness 98

FDA Law Blog

JUNE 3, 2025

We received a response to our post on the prescribing red flags indicating the likelihood of certain prescriptions filled by Walgreens pharmacies were invalid because they lacked a legitimate medical purpose or were not issued in the usual course of professional practice. Deborah Dowell et al., 1, Recommendation 3. Recommendation 1.

Clinical Practice 59

Clinical Practice Patient-Centered Patients Clinic 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.

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Manufacturing Hospital Healthcare Medical 81

FDA Law Blog

APRIL 20, 2021

Certain types of clinical decision-support software. Calculator/Data Processing Module for Clinical Use. Medical Device Data System. Remove non-device software functions intended for transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results. By McKenzie E.

Electronics 40

Electronics Medical Management Clinic 40

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. That did not happen.

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Clinic IT Provider Patient-Centered 59

FDA Law Blog

FEBRUARY 22, 2023

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec.

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Manufacturing Engineering Medical IT 64

FDA Law Blog

JUNE 29, 2022

For CDER specifically, the division must discuss the proposed rescission with CDER’s Medical Policy Council prior to notifying the sponsor. The Medical Policy Council’s role, as described in the MAPP, is to discuss decisions to rescind to ensure consistency in policy implementation across review divisions. randomization, blinding).”

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FDA Law Blog

JUNE 23, 2021

I have witnessed it inform whether clinical trial results are clinically meaningful (or not) as well as the selection and even development of primary endpoints. Cavazzoni lays out is the traditional way in which patients have informed drug benefit-risk decision-making: by setting the “clinical context” of the disease.

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Patients Patient-Centered Clinic Community 52

FDA Law Blog

FEBRUARY 26, 2024

With respect to safety, FDA raised concerns that differences in the either the concentration or total drug content of a parenteral product can introduce risk for medication errors, like dosing errors from difficulty in switching from the Reference Product. FDA thus disagrees that such differences are not clinically meaningful.

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IT Provider Clinic Medical 59

Annals of Family Medicine

NOVEMBER 20, 2024

Setting or Dataset: Academic primary care system pediatric and family medicine clinics Population Studied: 366 randomly sampled medically-homed children who did not receive the HPV vaccine at or prior to their 11 year old well child check between March 1st 2015 and February 29th 2016 Intervention/Instrument: N/A Outcome Measures: Initiating HPV vaccination (..)

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FDA Law Blog

MARCH 17, 2022

We blogged on the final 2016 guideline here on March 17, 2016). Proposed 2022 CDC Clinical Practice Guideline for Prescribing Opioids, 87 Fed. et al, CDC Clinical Practice Guideline for Prescribing Opioids-United States, 2022, CDC. 2016 Guideline. CDC Clinical Practice Guideline, 10. 7,838 (Feb.

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Patient-Centered Clinical Practice Patients Individual 75

Physician's Weekly

JUNE 18, 2025

1, 2016, to Jan. In all studies, exposure corresponded to use of cannabis, with one study focused on medical cannabis. “Cannabis needs to be incorporated into the framework for prevention of clinical cardiovascular disease,” write the authors of an accompanying editorial.

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Clinic Medical 52

Annals of Family Medicine

NOVEMBER 20, 2024

Population Studied – The Vizient® Clinical Data Base was queried for inpatient discharges between January 2016 and February 2024 with an ICD-10-CM diagnosis code for naegleriasis (B60.2). Objective: Determine the epidemiological trends for patients infected with N. Study Design and Setting: Retrospective case series.

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Diagnosis Patients Clinic Individual 130

BMJ

FEBRUARY 8, 2021

7 The same degree of focus has not been paid to misuse of other prescription medications which also have high abuse potential among youth, including medications such as prescription stimulants, tranquilizers, and sedatives. misuse of prescription medications). 2 Opioids contribute a large share of this overdose crisis.

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Medical Holistic Care Healthcare Healthcare Professional 40

FDA Law Blog

JUNE 9, 2025

These events marked a turning point in expanding representation in clinical studies and opening the door to more personalized medical care. These events marked a turning point in expanding representation in clinical studies and opening the door to more personalized medical care.

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Clinic IT Healthcare Medical 59

The Clinical Problem Solvers

DECEMBER 20, 2021

Highlight how structural racism against Asian-Americans surfaces in clinical settings, and describe means of counteracting such structures. provision in only English +/- Spanish), limitations of medical technology (i.e., provision in only English +/- Spanish), limitations of medical technology (i.e., January 19, 2021.

Community 52

Community Patient-Centered Relationship Healthcare 52

FDA Law Blog

JANUARY 18, 2024

FDA conducted the eight-factor scheduling analysis required by the CSA in 2016 and found that marijuana continued to meet the scheduling criteria for remaining in schedule I. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed.

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Medical Physicals IT Healthcare Professional 69

FDA Law Blog

FEBRUARY 5, 2024

Livornese — Last week FDA issued a new draft guidance titled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products. The Draft Guidance emphasizes that study team should not answer the questions based on observation or even on existing medical records.

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Clinic Medical Provider Management 59

FDA Law Blog

NOVEMBER 29, 2022

Houck — On November 4th, CDC issued its revised guideline on prescribing opioids for pain as an expansion and update of its 2016 CDC Opioid Prescribing Guideline. CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022. Expected clinical benefits should be weighed against risks before beginning therapy.

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Patients Patient-Centered ER Individual 52

FDA Law Blog

JUNE 7, 2021

However, the FDA guidance goes on to say in some cases, additional context is needed by specifically inserting a sentence in the indications statement that: no clinical benefit has been established. be “reasonably likely to predict” ultimate clinical benefit). be “reasonably likely to predict” ultimate clinical benefit).

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Permanente Medicine

APRIL 29, 2025

From 2012 to 2016, death rates from colorectal cancer among Black people were nearly 40% higher than in whites and double that seen in Asians and Pacific Islanders, according to the American Cancer Society. Levin, MD , a Kaiser Permanente Division of Research scientist and gastroenterologist with The Permanente Medical Group.

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Screening Checkup Integrated Care Electronics 52

FDA Law Blog

MAY 5, 2024

Former DEA Administrators and National Drug Policy Directors asserted that the science demonstrating marijuana’s high addictive potential, its lack of accepted medical use, and rescheduling impact on prosecuting drug trafficking organizations required marijuana to remain in schedule I. Letter to U.S. treaty obligations in rescheduling.

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Medical Manufacturing Physicals Healthcare Professional 95