FDA Law Blog

NOVEMBER 20, 2024

Since the first issuance of FDA’s guidance Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” in 2016, sponsors submitting premarket submissions to FDA have had the option of using these techniques to evaluate certain biocompatibility endpoints.

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Provider Medical Manufacturing Consulting 59

PEMBlog

SEPTEMBER 24, 2024

Most patients are afebrile by the third day of treatment and clinically improved within two weeks. Management of Congenital Lung Malformations. doi: 10.1128/microbiolspec.TNMI7-0032-2016. An important point from this case is to consider CT imaging when a child has persistent or recurrent pneumonia. Congenital Lung Malformations.

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Diagnosis Diagnose Patients Asthma 52

FDA Law Blog

FEBRUARY 22, 2023

The generation of HF data is a detailed and fairly burdensome process, although certainly short of a full-blown clinical study. And HF‑related AI requests are especially nerve‑racking to manage, because of the ever‑present threat that the study must be repeated to adequately respond. By Jeffrey K. In one way, this is good news.

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Manufacturing Engineering Medical IT 64

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

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. They do apply, however, to prescribing for pain management upon discharge.

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Patients Patient-Centered ER Individual 52

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Livornese — Last week FDA issued a new draft guidance titled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products. When finalized, the Draft Guidance will take the place of the 2016 guidance Collection of Race and Ethnicity Data in Clinical Trials.

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Clinic Medical Provider Management 59

Physician's Weekly

JUNE 11, 2025

Despite the emphasis on U=U as a key HIV prevention strategy since 2016, none of the included studies explicitly described U=U or U=U messaging as an intervention component,” the researchers wrote. This message should be incorporated into counseling during routine clinic visits, especially for people recently diagnosed with HIV.

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Mental Health Healthcare Professional Community Healthcare 114

GeriPal

OCTOBER 10, 2024

And they begin on today’s podcast with one clinical ask: everyone should be a generalist and a specialist. They are looking to build on both their research and clinical programs and are interviewing candidates for the Associate Chief of Research and for full-time physician faculty to join them in the inpatient and outpatient setting.

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Screening IT Families Family 120

GeriPal

APRIL 14, 2022

Management of chronic pain in the elderly: focus on transdermal buprenorphine. So I have thought about this for months, maybe years since your 2016, cycle blog, but we have picked Under Pressure by David Bowie and Queen. This is both a research and a clinical interest of yours. And how am I going to manage their pain?

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Illness Patient-Centered IT Patients 102

GeriPal

MARCH 28, 2024

Ten years ago we would have been hard pressed to find 3 clinical trial abstracts submitted to the annual meeting, much less high quality randomized trials with robust measures, sample sizes, and analytics plans. Eric: And that’s similar to the 2016 JAMA paper, right? Did it negate everything from the 2016 trial?Palliative

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Consulting Patient-Centered IT Patients 115

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. Deaths per 100,000 for Hispanic, white, and Asian patients decreased to 20 during the same time period.

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Screening Checkup Integrated Care Electronics 52

FDA Law Blog

MAY 5, 2024

The White House Office of Management and Budget will review the rescheduling proposal. FDA/HHS Analysis, 2023 FDA/HHS last conducted an eight-factor analysis of marijuana in 2016 and concluded that marijuana continued to meet schedule I criteria. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed.

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Medical Manufacturing Physicals Healthcare Professional 95

The Clinical Problem Solvers

MAY 30, 2022

Kozhimannil—the Distinguished McKnight University Professor in the Division of Health Policy and Management at the University of Minnesota and Director of the Rural Health Research Center. Published April 20, 2016. The Clinical Problem Solvers Podcast – Antiracism in Medicine Series. Healthcare. 2020;8(1):100367.

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Community Patient-Centered Families Family 52

GeriPal

APRIL 10, 2025

Why this study was a success due to the sheer size (nearly 100,000 patients in about 30 EDs) of the study, and the fact that, as far as the investigators know, all study sites continue to employ the clinical decision support tool. And then we had clinical decision support. What is a cluster stepped wedge randomized trial? Long overdue.

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Patient-Centered IT Hospital Patients 77

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.

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IT Hospital Screening Patients 64

GeriPal

FEBRUARY 29, 2024

But when we have people in rural areas of California, so we don’t know our clinical site, we go from San Francisco all the way to the Northern California border, super rural areas. Alex: And, it means pain management. ” I think we started the blog in 2007 or 2008, we were doing that up until 2016. ” Love it.

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IT Patient-Centered Illness Education 126

PEMBlog

MARCH 27, 2024

This episode will help you better prepare for and manage children with inborn errors of metabolism in the Emergency Department. 2016 Jan;37(1):3-15; quiz 16-7, 47. As always, I’m your host, Brad Sobolewski, and this episode focuses on the management of children with metabolic disorders who present to the emergency department.

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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. Working with our clinical decision support team and thinking about where that could be. Heather: Yeah.

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Patient-Centered Illness Healthcare IT 115

GeriPal

JULY 28, 2022

But at that time I was struck by how in that field, there wasn’t a focus or really interest in symptom management and support for patients and their families. They supported patients, they gave them a holding environment, they did symptom management, yada, yada, yada, like all the things we know palliative care clinicians do.

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Illness Hospital Patient-Centered Patients 110

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. Working with our clinical decision support team and thinking about where that could be. Heather: Yeah.

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IT Patient-Centered Healthcare Illness 105

FDA Law Blog

JUNE 19, 2023

Moreover, while rulemaking may shield FDA from some procedural challenges, the imposition of substantive new requirements on clinical laboratories would be very likely to prompt lawsuits on other grounds. Cato — The long-running saga of FDA regulation of laboratory-developed tests (LDTs) has taken yet another new turn.

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IT Management Clinic Medical 56

PEMBlog

DECEMBER 14, 2023

Learn all about diagnosis and management of this common problem in this brief podcast episode. 2016 Apr;83:78-83. But it might underestimate it because lots of mild cases don’t actually present clinically, and they’re not diagnosed endoscopically. Isaac A, Zhang H, Soon SR, Campbell S, El-Hakim H.

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Diagnosis IT Diagnose Patients 52

GeriPal

JUNE 30, 2022

Should she be treated non-operatively, with aggressive symptom management? So when I was a resident at Cleveland Clinic, I got to see really cutting-edge technology, some of the best surgeons in the country, and perhaps in the world, operating on patients. What does it mean for functional status, symptom management, location of care?

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Patient-Centered Complication Patients IT 101

GeriPal

JANUARY 11, 2024

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. You get me with one-finger-chords on the guitar if you’re watching on YouTube (best I could manage). Four percent. Bill, welcome back to GeriPal.

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Illness IT Medical Provider 144

GeriPal

AUGUST 25, 2022

And yet, we know little about the clinical experience of people with dementia in hospice. My interest in this paper and this topic goes back a long time and is based on my clinical experience as a hospice nurse, where I was taking care of what I felt like and what we’ve confirmed with research is about half of my patients.

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Families Family IT Patients 106

GeriPal

FEBRUARY 15, 2024

Wait, first of all, what’s the incidence of calling EMS for falls over almost a decade, I think like 2007 to 2016, and what happens to people afterwards? Same thing with kind of medication management. Eric: So you both published a paper in JAGS, what, 2018, ’19 looking at what happens to people? Alex: The Wayback Machine.

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Community Transportation IT PCP 115

GeriPal

AUGUST 24, 2023

And so the importance of the picture and the epiphany that really came many years later, I published a paper in the Journal of Clinical Oncology called Dignity in the Eye of the Beholder. How do you do that in clinical practice, in a way that doesn’t take five hours of sitting down with somebody? Eric: So how do you do that?

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Patient-Centered Patients IT Illness 98

GeriPal

MARCH 30, 2023

As I was cleaning up my office, I found something I’d written in 2016. It isn’t the randomized trials, which are very important, obviously, for the work that all of us do, the work that I do clinically. They are coming to you often with something very, very deeply personal. I’ve never submitted a piece of my mind.

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IT Patient-Centered Patients Healthcare 96

BMJ

JUNE 25, 2021

1 Clinical guidelines internationally recommend statin therapy for both primary and secondary prevention of CVD, making statins one of the most frequently prescribed drugs in industrialised countries. In clinical practice, patients are not fixed on a certain treatment regime and can start and stop at any time.

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Primary Care Clinical Practice Electronics Clinic 40

GeriPal

JULY 25, 2024

Eric 04:39 Yeah, I see it used on inpatient, side on consult clinics in hospices. Eric 07:03 And those classic studies, were those done in the hospital and PALP care units and clinic? The folks that we were seeing either in clinic or inpatient, were probably a lot sicker than the ones that we’re seeing now.

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Families Family Patient-Centered Patients 106

GeriPal

DECEMBER 21, 2023

This model will give participating programs a per-member-per-month payment to offer care management, care coordination, and other services such as caregiver training, disease education, and respite. I didn’t know how to manage it. 2015, 2016. And I was terrified. And I thought, “Ah, it would be awesome to go there.”

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Patient-Centered IT Families Family 125

GeriPal

APRIL 20, 2023

I would talk about this, except I was a clinician, and I’m seeing these folks in the hospital and in clinic. The journal section’s requirements are the same as for a clinical investigation. ” It was in my slide deck. It’s like, “Wait, they’re not 25 to 44. ” I thought, “Am I missing it?

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Mental Health IT Community Individual 123

FDA Law Blog

NOVEMBER 8, 2022

Fellow panelist, August Bencke Geyer, who serves as Deputy General Manager of the Medical Devices Office at ANVISA (Brazilian Health Regulatory Agency) expressed enthusiasm and indicated that Brazilian regulators are watching closely to see how the program unfolds. It’s an easy way to manage the transition.”.

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Medical Manufacturing Patient-Centered Provider 59

FDA Law Blog

SEPTEMBER 13, 2021

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.

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Manufacturing Supply Chain Patient-Centered Utilities 98