FDA Law Blog

AUGUST 2, 2022

As a reminder, cannabis remains a schedule I substance under the federal Controlled Substances Act (“CSA”), which by definition means it does not have an accepted medical use in treatment in the United States and thus cannot be legally sold or marketed for any purpose. 21 U.S.C. § 812(b)(1).

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BMJ

JULY 17, 2020

A multilayered view of stigmatizing discourses lays the foundation for eliciting a series of suggestions for quelling stigma, to be implemented at the individual, community, and national levels, as suggested by the WHO. Ebola-related stigma in Ghana: Individual and community level determinants. Scholars such as Wen et al.

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FDA Law Blog

FEBRUARY 28, 2022

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ). Valentine & Larry J.

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The Clinical Problem Solvers

DECEMBER 16, 2020

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. These factors include a high-protein diet, muscle mass, creatinine generation, and certain medications. link] Tsai J.

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Clinic Education Clinical Practice Patient-Centered 52

FDA Law Blog

DECEMBER 13, 2023

GeMDAC was established to advise FDA regarding treatments under the purview of CDER’s Division of Rare Diseases and Medical Genetics (DRDMG), within the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine. Note that FDA is currently soliciting applications to staff this committee.

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FDA Law Blog

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s blog here. 18 U.S.C. § 18 U.S.C. § 220(e)(2).

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Lab Testing Referral Individual Patient-Centered 52

PEMBlog

APRIL 20, 2023

Emicizumab (Hemlibra) was approved in 2018 for routine bleeding prophylaxis in hemophilia A with or without inhibitors. It is therefore no hyperbole to say that Emicizumab has been a life-changing therapy for individuals with hemophilia A who have factor VIII inhibitors (alloantibodies against factor VIII). This is a black box warning.

Individual 52

Individual Patient-Centered Patients IT 52

Aspiring Minority Doctor

APRIL 17, 2021

When I first applied in the 2018 cycle, the total I spent was $1910 ($1686 in the actual match and the rest during SOAP.reviewing my payment history now). Retracted] had a super fun survey that really focused on my interests and individuality outside of medicine. It all adds up.

Medical Student 52

Medical Student IT Telemedicine Medical 52

GeriPal

MAY 19, 2022

I think part of it’s the math, but I think what really happened is, I think the story here is that in 2018, MD Anderson published this really landmark study by Dr. Reddy and her colleagues about going from IV Dilaudid to other to oral Dilaudid, oral hydromorphone, I should say, oral morphine and oral oxycodone. Drew: I agree in part.

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FDA Law Blog

JULY 25, 2023

The canary in the coal mine for nitrosamines was their 2018 appearance in blood pressure medications called sartans. And FDA has had numerous with meetings with individual stakeholders seeking a better understanding of their approach to nitrosamines. What is FDA doing about NDRSIs? Seek, and ye shall find, so FDA hopes.

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IT Manufacturing Individual Medical 52

FDA Law Blog

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s blog here. 18 U.S.C. § 18 U.S.C. § 220(e)(2).

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Lab Testing Individual Referral Patient-Centered 40

The Clinical Problem Solvers

AUGUST 25, 2020

Trainees may use this foundation to question how this might impact their medical education and think about this educational legacy may be reformed through curricular and structural changes at their institutions. Trainees We encourage trainees to reflect on the ways they have been socialized to learn and think about racism in our country.

Community 52

Community Patient-Centered Relationship Education 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.

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GeriPal

JUNE 8, 2023

When I’m on palliative care consults and attending in our hospice unit we have to counsel patients about deprescribing and de-intensifying diabetes medications. Our last podcast was with Laura Petrillo in 2018 – 5 years ago seems ancient history – though many of the points still apply today (e.g. How high is too high?

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Diabetes Management Patient-Centered Families 74

FDA Law Blog

APRIL 3, 2022

The prior BOP regulations became effective April 1, 2018, requiring owners to report the loss of any controlled substance, even single doses, to the Board. Injectable multidose injectables, infusion medications or unidentified other multi-dose unit-two or more multi-dose vials, infusion bags or other containers.

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IT Provider Medical Individual 52

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. Fiscal Year.

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FDA Law Blog

JULY 10, 2023

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. By Philip Won & Adrienne R.

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

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Patients Patient-Centered Clinic Community 52

FDA Law Blog

FEBRUARY 27, 2024

2018) , Arnold Partnership v. Consequently, because both applications were approved at the same time, both applications represent the first permitted commercial marketing or use of the product or the individual active ingredients, as outlined under 35 U.S.C. Ezra Ventures LLC, 909 F.3d 3d 1367 (Fed. Rogan , 246 F. 2d 460 (E.D.

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Patients IT Provider Individual 59

Physician's Weekly

JUNE 17, 2025

Daily exposure to a phthalate commonly used in plastic products was linked to more than 356,000 cardiovascular deaths globally in 2018, research shows. DEHP is commonly found in food packaging, furniture, shoes, flooring, shower curtains, medical equipment, and many other products. of global cardiovascular mortality in 2018.

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FDA Law Blog

SEPTEMBER 20, 2021

STAR aims to facilitate earlier access to novel uses of existing therapies for patients with a serious condition with unmet medical needs. In brief, the process begins with a request for a presubmission informal teleconference (or alternatively, a discussion as part of a pre-sNDA or pre-sBLA meeting).

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

BMJ

FEBRUARY 8, 2021

Two out of three drug overdose deaths in 2018 involved an opioid – be it prescription opioids, heroin, or synthetic opioids. 6 As a result of these and many other actions, the death toll from opioid overdose fell by more than 4% between 2017 and 2018. misuse of prescription medications). 3 To respond to this crisis, the U.S.

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Medical Holistic Care Healthcare Healthcare Professional 40

Physician's Weekly

JUNE 22, 2025

These included how well physicians demonstrated respect, listened to individuals, explained information, and spent enough time with them. These outcomes were adjusted for variables including age, race, ethnicity, income, health insurance, educational status, and coexisting medical conditions.

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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. Then, in 2016, FDA noted its goal to streamline MDR requirements in the Medical Device User Fee Amendments of 2017 (MDUFA IV) commitment letter.

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Medical Manufacturing Individual Provider 59

The Clinical Problem Solvers

FEBRUARY 8, 2023

Between 2007 – 2019, Black individuals experienced a higher death rate for opioid overdose deaths than any other racial or ethnic group. These narratives have vilified individuals who would benefit from comprehensive, person-centered substance use treatment, rather than incarceration and other adverse harms.

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Community Patient-Centered Mental Health Board-Certified 52

FDA Law Blog

OCTOBER 17, 2023

Compared to the previous version, the new guidance document highlights that the Breakthrough Devices Program may also be applicable to certain devices that benefit populations impacted by health and/or healthcare disparities and to certain non-addictive medical products to treat pain or addiction. By Philip Won & Lisa M. 360e-3)).”

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Medical Diagnosis Healthcare Clinic 53

GeriPal

MARCH 2, 2023

JAMA Surgery 2018 Gabapentin and mood stabilizers in the Nursing Home Setting: Antiepileptic prescribing to persons living with dementia residing in nursing homes: A tale of two indications. It’s not a controlled substance medication. Eric: So I heard gabapentin is the 10th most commonly prescribed medication in the US.

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Patient-Centered IT Healthcare Medical 96

FDA Law Blog

JUNE 24, 2021

Cato — On June 18th, FDA published a draft guidance document titled Remanufacturing of Medical Devices , which has been several years in the making. In 2016, FDA opened a docket seeking comments on “service, maintenance, refurbishment, and alteration of medical devices” by third parties (see our blog post here ). By McKenzie E.

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Manufacturing Medical Provider IT 52

GeriPal

FEBRUARY 15, 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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Community Transportation IT PCP 115

GeriPal

JULY 21, 2022

Eric: For those of you don’t know, Emmy was on our podcast back in 2018 … man, pre-COVID times. Emmy: But we know that physiologic changes with aging, like decreasing night vision and so forth, as well as medications, as well as medical conditions, can all affect whether you can drive. Weren’t those the days?

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Families IT Family Diagnosis 102

GeriPal

AUGUST 17, 2023

So what is the role of individuals like geriatricians in prescribing amyloid antibodies and caring for individuals who are receiving them? And I do think geriatricians need to as individuals make that decision, largely based on their comfort with the diagnostics and the specifics of the therapeutics. I’m a prescriber.

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Patient-Centered IT Clinic Patients 98

GeriPal

JUNE 22, 2023

Summary Transcript Summary In the early 1990’s, California Medical Facility (CMF) created one of the nation’s first licensed hospice units inside a prison. Alex: We are in the California Medical Facility and we will ask our guest about that. I’ve known Michele a long time, since the Joint Medical Program. Michele: Yep.

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Families Family IT Community 132

GeriPal

MARCH 24, 2022

2018 Systematic Review of Systematic Reviews on ACP. And I don’t think necessarily, that appointment needs to be a medicalized process. Although, certainly when you start facing complications of serious illness, it is increasingly important to engage as individuals and conversations about goals, values, and preferences.

Illness 73

Illness IT Healthcare Patient-Centered 73

GeriPal

APRIL 3, 2025

We covered: The first parody song I wrote, for AGS 2018 in Orlando , about this article by Nancy Schoenborn on how to discuss stopping cancer screening. Annie 02:31 So if you go to the A G S meeting every year, you know that this group of three individuals comprises the AGS literature update. Alex joined in 2018.

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IT Hospital Screening Patients 64

GeriPal

FEBRUARY 6, 2025

We have two new FDA-approved medications that reduce that amyloid buildup and modestly slow down the progression of the disease. He is associate professor at the University of Wisconsin and medical director of their Alzheimer’s Disease Research Center. Of these interventions in those individuals. Great to be back.

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Primary Care Diagnosis Screening IT 96

GeriPal

MAY 12, 2022

Raj: It was indeed very, very gradual, and the seeds were sown when I was a medical student. So, we formed this organization called Pain and Palliative Care Society in the Northern Kerala city of Kalakkad based in the government medical college. Raj: That’s one of the high tech medical absurdities that we have developed.

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GeriPal

APRIL 24, 2025

And so this term was developed by our group to capture either non traditional therapies or really conventional medical therapies that patients may be pursuing with little hope of reaching a goal of care and significant risk. Eric 06:58 It could be CPR in an individual with metastatic cancer in the icu. Did I say that correctly?

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Patient-Centered IT Patients Illness 77