FDA Law Blog

JULY 17, 2024

Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations. clinical pharmacology/biomarkers, animal models, real-world evidence and other externally controlled comparisons [e.g.,

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Common Sense Family Doctor

DECEMBER 14, 2024

Concerns about overdiagnosis of clinically insignificant prostate cancer through prostate specific antigen (PSA) screening motivated the 2018 American Academy of Family Physicians’ (AAFP) recommendation against routine screening for prostate cancer. Explaining the AAFP’s position, Drs.

Routine Screenings 52

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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. Yet, as Tenkorang 7 made the point, it is simply not enough to only implement approaches at the community level.

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FDA Law Blog

OCTOBER 30, 2022

This draft guidance proposes updates to FDA’s Breakthrough Devices Program, which is outlined in a separate December 2018 guidance document. FDA intends to incorporate these updates into the December 2018 Breakthrough Devices Program guidance after considering public comment.

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Diagnosis Clinic Provider IT 59

FDA Law Blog

AUGUST 2, 2022

Cole providing guidance to U.S. However, in January 2018, then-Attorney General Jeff Sessions rescinded the Cole and Ogden Memos. It is worth noting that the CSA provides that HHS medical and scientific findings on drugs are controlling. 3 (July 5, 2022) [hereinafter CRCC Letter]. 4591) on July 21st.

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FDA Law Blog

JANUARY 15, 2024

If you made it through the first 2 pages of the opinion, this Court’s answer is clear: FDA flagrantly violated the APA in denying those flavored e-cigarette applications due to the Agency’s utter failure to provide comprehensible instructions and consistent policies. FDA also directed manufacturers to produce detailed marketing plans.

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FDA Law Blog

JUNE 15, 2022

Kirschenbaum — In 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule to significantly decrease the rate the government will reimburse 340B hospitals in 2018 for outpatient prescription drugs from average sales price (“ASP”) plus 6% to ASP minus 22.5%. 52494 (Nov. Becerra, No. 20-1114, 596 U. S. _ (2022).

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Annals of Family Medicine

NOVEMBER 20, 2024

Objective To provide a comprehensive overview of primary care use among community-dwelling persons with dementia in Quebec from 2018 to 2020. Population Studied Community-dwelling persons aged 65 and older with a prevalent diagnosis of dementia on March 1st of 2018, 2019, and 2020. 60.8%, 60.2%, and 58.8%

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FDA Law Blog

MAY 2, 2022

In response to states authorizing and legalizing marijuana while it remained a schedule I substance federally, Deputy Attorney General James Cole provided guidance in a memorandum to U.S. Attorney General Jeff Sessions rescinded prior DOJ guidance on marijuana enforcement, including the Cole Memo, in January 2018. Jefferson B.

Manufacturing 52

Manufacturing Medical IT Community 52

The Clinical Problem Solvers

DECEMBER 16, 2020

September 12, 2018. J Epidemiol Community Health. 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. Links References discussed throughout episode Tsai J. link] Tsai J.

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Clinic Education Clinical Practice Patient-Centered 52

FDA Law Blog

FEBRUARY 27, 2023

The rule would permit a practitioner using a telemedicine encounter to prescribe controlled substances without an in-person visit under various situations involving both an audio-visual telehealth evaluation, or an in-person evaluation performed by a “referring” provider. 21 U.S.C. § 802(54)(D)(i).

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Telemedicine Telecommunication Telehealth Medical 59

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. § 18 U.S.C. §

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Lab Testing Individual Referral Patient-Centered 52

FDA Law Blog

JUNE 23, 2021

Janet Woodcock’s leadership, identified the need for more systematic patient engagement — a way to improve representativeness and be more proactive rather than reactive to interacting with patient communities. However, in the coming days we hope to do so and may provide our thoughts in subsequent posts.

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Patients Patient-Centered Clinic IT 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. § 18 U.S.C. §

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Lab Testing Individual Referral Patient-Centered 40

GeriPal

JUNE 8, 2023

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. So learning more about how to inform providers on how to make decisions about de-prescribing based on prognosis, based on diabetes type, based on their oral intake and their goals.

Diabetes 74

Diabetes Management Patient-Centered Family 74

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. And yet, after assisting the older adult to their feet, the EMS providers would leave. So Carmen and Katie developed an EMS Community Partnership program.

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Community Transportation IT PCP 115

The Clinical Problem Solvers

FEBRUARY 8, 2023

Identify realistic solutions to drug policy reform that promote health equity among marginalized communities living in the United States. Screening for substance use and offering connections to treatment and community-based services are important strategies that clinicians can implement in their own practice today.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

Physician's Weekly

JUNE 19, 2025

The Health Resources and Services Administration projects a 50% increase in demand for geriatricians from 2018 to 2030, when the entire baby boom generation will be older than 65. “We step into places where other providers may not, and geriatrics is a prime example of that.” ” In 27 states and Washington, D.C.,

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Nurse Practitioner Family Families Primary Care 52

The Clinical Problem Solvers

MAY 30, 2022

As healthcare providers, we must listen to our patients and use the power of our presence to see birthing people’s full humanity and empowerment. Pearls Black and Indigenous birthing people are 3-13 times more likely to die in childbirth, with the rate varying by location and level of investment in communities.

Community 52

Community Patient-Centered Family Families 52

Physician's Weekly

JUNE 11, 2025

The systematic review of peer-reviewed intervention was published from 2018 to 2023. The researchers recommended including community members in intervention design, healthcare systems, and policies. Community-based organizations led by Black women may be even more impactful. PW: Why was it important to do this study?

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Mental Health Healthcare Professional Community Healthcare 114

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. 2 Opioids contribute a large share of this overdose crisis.

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Medical Holistic Care Healthcare Healthcare Professional 40

FDA Law Blog

OCTOBER 17, 2023

FDA previously released the final guidance document in December 2018 outlining the program’s principles, features, designation criteria, and other considerations. Additionally, the 2022 draft guidance suggested the addition of a new section to the 2018 guidance on reducing disparities in health and healthcare. Emphasis added.)

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Medical Diagnosis Healthcare Clinic 53

GeriPal

MAY 12, 2022

Prognosis communication and the subtle ways we may communicate it without intention. Community-based palliative care networks . And I believe it needs the community. Raj: So in Kerala, because it started with the involvement of laypeople, we included the community in care because the existing system had no space for this.

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Community IT Relationship Healthcare 115

GeriPal

JUNE 22, 2023

Michele: Yeah, so in May of 2018, there was an article by Suleika Jaouad in the New York Times Magazine, and they spent about two weeks in our hospice with us learning about the work that’s done. Michele: The article was 2018, but I think Bonnie read the article more recently. It’s by choice, just like in the community.

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Family Families IT Community 132

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. Eric: Any other interesting tidbits or facts that we should know as providers about gabapentin or Lyrica dosing or pharmacology? J Am Geriatr Soc.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

GeriPal

JULY 21, 2022

Eric: For those of you don’t know, Emmy was on our podcast back in 2018 … man, pre-COVID times. But then once it was open, started seeing a lot of other populations: not just our own hospital population, but a lot more just community members calling with concerns about driving. Weren’t those the days? Eric: Yeah.

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IT Family Families Diagnosis 102

GeriPal

OCTOBER 24, 2024

And then in 2018, when adult use was allowed in California, I think it gave people more permission, but the stigma is still there. I actually do some consulting work with a company called the Farmstand that’s based in a community called the Villages in Florida. I mean, I had a woman who completely got her life back.

Medical 99

Medical IT Patient-Centered Healthcare 99

GeriPal

SEPTEMBER 7, 2023

William: So ASCO decided to make a high priority this year to redo the guidelines, which were originally released in 2018. And because, it’s a little kid in a candy store, so many different choices for quote, unquote, “community oncologists,” and perhaps even for academic oncologists. Throw it in the trash.”

Patient-Centered 129

Patient-Centered IT Patients Clinic 129

FDA Law Blog

MAY 16, 2024

UMHS agreed to resolve the allegations in August 2018 for $4,300,000 and compliance with a three-year Memorandum of Agreement (“MOA”). The tech’s husband distributed the drugs in the community. Controlled substances are a necessary component in hospitals providing needed medical care to patients.

Hospital 59

Hospital Patient-Centered Medical Provider 59

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. Alex joined in 2018. This was 2018 in AGS Orlando, and they did a song about when to stop screening for cancer for colon cancer. Alex 05:15 Oh, really? And so we did this song.

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IT Hospital Screening Patients 64

GeriPal

MARCH 24, 2022

2018 Systematic Review of Systematic Reviews on ACP. And I would say too, as a primary care provider, it really doesn’t take that long to ask people about a surrogate decision maker. Susan: I will share in Indiana, we actually had that as our legal model, that there was a decision making by committee up until 2018.

Illness 73

Illness IT Healthcare Patient-Centered 73

GeriPal

FEBRUARY 6, 2025

We’ve had difficulty in recruiting and engaging in those communities, and that’s on our end. It’s not on the community’s end. So for primary care providers, you order that blood test, you own that. So it matters a lot to the person, to their family, to the community. And even a prostate cancer.

Primary Care 96

Primary Care Diagnosis Screening IT 96

GeriPal

MARCH 3, 2022

I want to say like 2017, 2018, something like that. I think there’s so much more, that’s known now about Alzheimer’s and out in the general public, hopefully providers are having these conversations, but we can’t really take too much comfort in it because of those findings that you just mentioned by John Tino.

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Patient-Centered Patients IT Hospital 96

Family Medicine Initiative

APRIL 10, 2024

Having Your Own Long-Term GP Can Save Your Life Patients who choose a GP rather than a specialist as their primary care provider have a 19% 8 lower mortality and produce 22% 9 -33% 8 lower healthcare spending. million people in 2018), shows that the longer you know your GP, the better off you are. Over time, communication improves.

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GeriPal

OCTOBER 3, 2024

I wonder if you could say a little bit more about the meta Institute in particular and what it is that clinicians today can do to learn, to be more present and learn about the need to be thoughtful and compassionate in the care that they provide people with serious illness. Frank, welcome to the GeriPal podcast. Frank 08:43 Well, briefly.

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IT Patient-Centered Patients Relationship 122

GeriPal

APRIL 21, 2022

To the deeper emotions – of loss and grief, of wonder and transcendence – that are at the heart of the complex care we provide. This has become a community of people all over the world who come together every week. And along the way, we really felt like we got to the heart of things. AlexSmithMD .

Patient-Centered 93

Patient-Centered IT Community Illness 93

GeriPal

MARCH 27, 2025

The reason I chose this song is because I’m currently working on bringing advanced care planning sessions to the Latino community. In our planning sessions, one of the biggest barriers to advanced care planning in this community is just talking about death. Why did you even bother doing this study? It’s a great question.

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Primary Care IT Clinic Patient-Centered 79