FDA Law Blog

APRIL 19, 2021

Genus Medical Technologies secured an important victory in the D.C. In Genus Medical Technologies v. FDA , the Court of Appeals ruled that FDA cannot regulate a medical product – in this case, the radiographic contrast agent barium sulfate – as a drug when the product meets the definition of a device.

Manufacturing 40

Manufacturing Government Medical IT 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.

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Clinic IT Provider Patient-Centered 59

FDA Law Blog

SEPTEMBER 5, 2023

Houck — Scheduling Criteria Under the Controlled Substances Act (“CSA”) Schedule I: • High potential for abuse; • No currently accepted medical use in treatment in the U.S.; and • Lack of accepted safety for use under medical supervision. and • Abuse may lead to moderate or low physical dependence or high psychological dependence.

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Medical IT Manufacturing Utilities 111

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

The Clinical Problem Solvers

DECEMBER 20, 2021

provision in only English +/- Spanish), limitations of medical technology (i.e., In addition to the physical wrongs done to the victims, these acts function as community stressors that harm the mental, emotional, and physical wellbeing of so many others. Insufficient language services (i.e., Anthology , edited by INCITE!

Community 52

Community Patient-Centered Relationship Healthcare 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.

Medical 95

Medical Manufacturing Physicals Healthcare Professional 95

GeriPal

FEBRUARY 15, 2024

The insight started when Carmen, an orthopedic surgeon-researcher, and Katie, a physical therapist- researcher participated in ride-alongs with EMS providers to patient’s homes. They were stunned by the number of calls for lift assistance for older adults who had fallen. laughter] Carmen, welcome to the GeriPal podcast! Carmen: Thank you.

Community 114

Community Transportation IT PCP 114

The Motivated MD

SEPTEMBER 19, 2024

A study by Johns Hopkins in 2016 found that medical errors may potentially be the third leading cause of death nationwide. ’ Though it often does not come with the attending salary, medical trainees are getting paid to perform a service, and hospitals provide retirement plans to these individuals. Set it and forget it!

Finance 52

Finance Individual Education Healthcare Professional 52

GeriPal

OCTOBER 10, 2024

social worker, chaplain), everyone should be able to ask a question or two about spiritual concerns, social concerns, or physical concerns. In 2018, survey data revealed that only 41% of survey adult practices had the full complement of funded core team members, which is up from 25% of 2016. But how about you!

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Screening IT Families Family 119

GeriPal

FEBRUARY 29, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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IT Patient-Centered Illness Education 126

GeriPal

JANUARY 11, 2024

Summary Transcript Summary Four percent of deaths in Canada are due to Medical Assistance in Dying (MAID). The number of people who have used MAID in Canada since it was legalized in 2016 has increased year on year from about 1,000 people in the first year to over 13,000 people in 2022. Four percent. This is Eric Widera.

Illness 144

Illness IT Medical Provider 144

GeriPal

JULY 28, 2022

And so I went into medical school wanting to cure cancer. I entered medical school and I did a course that was offered that’s called living with a life threatening illness. I entered medical school and I did a course that was offered that’s called living with a life threatening illness.

Illness 110

Illness Hospital Patient-Centered Patients 110

PEMBlog

MARCH 27, 2024

She aims to become a physician-scientist in pediatrics and medical genetics, engaging in bench-to-bedside research that utilizes multi-omics-based approaches to provide a molecular diagnosis and support personalized care for individuals with suspected rare genetic diseases and their families. 2016 Jan;37(1):3-15; quiz 16-7, 47.

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Consulting Individual Families Family 59

GeriPal

DECEMBER 8, 2022

And then we also have another Vas, many of the interviews are done by medical students or other healthcare trainees as part of their clinical rotation at the VA. So like I said, I got to meet Thor, I believe it was May, 2016. Depends om my audience. Eric: And what are you doing as far as a research project? Heather: Yeah. Oh my gosh.

Patient-Centered 115

Patient-Centered Illness Healthcare IT 115

GeriPal

APRIL 3, 2025

We used all of our political capital to make sure it happens in Chicago, which is where we started for the literature Updates back in 2016, back when it was just me and Ken, and then we brought in Alex, like two years later. Annie 05:16 So if you look back in history, I think Eric and Ken have been doing this since 2016. Go Cubs, go.

IT 64

IT Hospital Screening Patients 64

GeriPal

MARCH 28, 2024

Tom: So we did this study because patients who go through the stem cell transplant process face a lot of misery in terms of physical symptoms, psychological distress, anxiety, depression, and even a risk of PTSD afterwards, sort of like a medical trauma, you might think of it. Did it negate everything from the 2016 trial?Palliative

Consulting 115

Consulting Patient-Centered IT Patients 115

GeriPal

DECEMBER 15, 2022

And then we also have another Vas, many of the interviews are done by medical students or other healthcare trainees as part of their clinical rotation at the VA. So like I said, I got to meet Thor, I believe it was May, 2016. Depends om my audience. Eric: And what are you doing as far as a research project? Heather: Yeah. Oh my gosh.

IT 105

IT Patient-Centered Healthcare Illness 105

GeriPal

OCTOBER 5, 2023

And I’ve noticed how we can say things like, you’re not a surgical candidate or you’re too weak to get more chemotherapy, but we can never really talk about CPR as a medical procedure in the ways we talk about other procedures and can make recommendations and offer reasoning about those procedures. This is Eric Widera.

Illness 136

Illness IT Patient-Centered Families 136

GeriPal

AUGUST 24, 2023

Summary Transcript Summary I hear the word dignity used a lot in the medical setting, but I’m never sure what people mean when they use it. Medical Assistance in Dying and Palliative Care: Shared Trajectories Transcript Eric: Welcome to the GeriPal Podcast. Had multiple physical, psychological complications as a result of that.

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Patient-Centered Patients IT Illness 98

FDA Law Blog

MAY 21, 2024

We wondered how given that HHS and the Drug Enforcement Administration (“DEA”) conducted eight-factor scheduling analyses in 2016, concluding that there was “no substantial evidence that marijuana should be removed from Schedule I.” 12, 2016) ; Denial of Petition to Initiate Proceedings to reschedule Marijuana, 81 Fed. 12, 2016).

Physicals 69

Physicals Medical Clinic Emergency Room 69

FDA Law Blog

FEBRUARY 11, 2024

The former officials implore following the science demonstrating marijuana’s high addictive potential, its lack of accepted medical use, and the rescheduling impact on prosecuting drug trafficking organizations. There has been no evidence that marijuana’s schedule should change since the last rescheduling review in 2016.

Medical 59

Medical Healthcare Professional Community IT 59

GeriPal

JULY 25, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Families 106

Families Family Patient-Centered Patients 106

GeriPal

APRIL 20, 2023

These were usually very physically demanding, low paid, often usually non-union work, that they worked their whole lives and were hanging on by their fingernails. I remember deep in the recesses, 2016, I think it was, a New England Journal piece came out saying that we need to reframe the debate about cost. Margot: Yeah. That was me.

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Mental Health IT Community Individual 123

GeriPal

DECEMBER 21, 2023

Too many people do because it’s really hard to keep their loved ones at home for the cost, the enormous financial, mental and physical strain for the family. 2015, 2016. And then 2016 after CMMI finished the evaluation, it looked good, nothing happened. But for other- Diane: And it’s on the medical side.

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Patient-Centered IT Families Family 125