GeriPal

MAY 19, 2022

It depends on the clinical situation. So, every single [inaudible 00:05:10] there is per the table, in an equianalgesic relationship to one another. As I’ve been blogging about this for a couple months now, I’m really trying to find anyone who loves these things. Eric: All right. That’s one aspect of it.

IT 139

IT Patients Individual Relationship 139

FDA Law Blog

OCTOBER 2, 2023

The eagerly anticipated guidance, Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence (i.e., In the December 2019 Guidance, FDA writes that the clinical context for a disease (i.e., As articulated by FDA, “[t]he quantity (e.g.,

IT 64

IT Clinic Provider Medical 64

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. What Dr. 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.

Patients 52

Patients Patient-Centered Clinic IT 52

FDA Law Blog

NOVEMBER 28, 2023

Gibbs — Shortly before the Thanksgiving holiday, FDA announced with no fanfare that it would be holding a Molecular and Clinical Genetics Panel meeting this Wednesday November 29. By Allyson B. Mullen & Jeffrey N. The docket will remain open through December 29.

Relationship 64

Relationship Screening IT Clinic 64

FDA Law Blog

SEPTEMBER 6, 2022

As the new Federal Register notice explains, FDA issued the 2016 Guidance in question and answer format to respond to the most frequently asked questions about charging for investigational drugs provided under an IND for either clinical trials or expanded access for treatment use under 21 CFR section 312.8. Changes from the 2016 Guidance.

Clinic 52

Clinic Manufacturing Patients IT 52

FDA Law Blog

MAY 8, 2023

In addition, manufacturers should identify whether the modifications will apply to all devices in the field (referred to as global adaptations) or will be implemented based on a specific clinical site or individual patients” (referred to as local adaptations).

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Manufacturing Provider Medical IT 98

FDA Law Blog

JANUARY 6, 2022

220 and was described on HP&M’s blog here. In general, EKRA prohibits, knowingly and willfully, soliciting, receiving, paying or offering kickbacks in exchange for referring to, inducing a referral to, or using the services of a recovery home, clinical treatment facility, or laboratory. EKRA is codified at 18 U.S.C. § 18 U.S.C. §

Lab Testing 52

Lab Testing Referral Individual Patient-Centered 52

FDA Law Blog

OCTOBER 10, 2023

Other key drug leadership positions that Dr. Beitz served in at FDA include Acting Deputy Director for Clinical Sciences of OND, Director of the Division of Drug Risk Evaluation in the Office of Surveillance and Epidemiology and Acting Deputy Director and Clinical Team Leader in the Division of Oncology Drug Products.

Patient-Centered 49

Patient-Centered Relationship Clinic Management 49

FDA Law Blog

OCTOBER 14, 2021

Rather, FDA seems intent on regulating RAS devices almost as if they were therapeutics responsible for long term clinical outcomes. It is well out of bounds for FDA to regulate them as if they were a determinant of long term clinical outcomes. Gone are the days of tool type indications for this type of device. 21 U.S.C. §

Patient-Centered 52

Patient-Centered Healthcare Manufacturing Provider 52

FDA Law Blog

FEBRUARY 27, 2023

180 days past May 11, 2023) for those telemedicine relationships established during the COVID-19 emergency. Comments, including data from research and clinical practice, that provides evidence that an alternate maximum day supply (other than the proposed 30-day supply). within 30 days) in the doctor-patient relationship.

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Telemedicine Telecommunication Telehealth Medical 59

FDA Law Blog

SEPTEMBER 20, 2021

Torrente, explained in a previous post , in-person meetings create important opportunities for building rapport, and lead to more robust dialogue and collegial relationships between the Agency and sponsors. Some of these will be subjects of more detailed posts in the future and readers should keep an eye on the blog for additional coverage.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law Blog

JANUARY 6, 2022

220 and was described on HP&M’s blog here. In general, EKRA prohibits, knowingly and willfully, soliciting, receiving, paying or offering kickbacks in exchange for referring to, inducing a referral to, or using the services of a recovery home, clinical treatment facility, or laboratory. EKRA is codified at 18 U.S.C. § 18 U.S.C. §

Lab Testing 40

Lab Testing Individual Referral Patient-Centered 40

FDA Law Blog

JULY 5, 2023

While section 503B expressly does not require a patient-specific prescription, FDA clarifies that Congress evidently did contemplate a “connection” (our words…) between an outsourcing facility and the prescriber; the more attenuated that relationship, the more an outsourcing facility starts to resemble a conventional drug manufacturer.

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Supply Chain Manufacturing Physicals Healthcare 52

FDA Law Blog

DECEMBER 12, 2022

This form lists important risks, including those known or reported to be associated with the use of the LASIK laser devices based on information from clinical trials, scientific literature, and reports from patients who have undergone LASIK. intrusion [into] the doctor-patient relationship. After reviewing the information.

Manufacturing 52

Manufacturing Provider Patients IT 52

Pamela Wible MD

JUNE 20, 2025

Characterized by cynicism, exhaustion, and reduced job satisfaction, physician burnout can lead to devastating personal and professional consequences, including strained relationships, substance abuse, early retirement, and even suicide. Now we’re getting somewhere. But is it really moral injury?

Medical Student 246

Medical Student Diagnosis Physicals Medical 246

PEMBlog

OCTOBER 2, 2024

I’ll dive into the latest clinical practice guidelines and discuss evidence-based approaches to diagnosis and treatment. Understanding dyspepsia and its clinical presentation. Now, in the pediatric emergency department, the diagnosis of reflux is primarily clinical. A key feature of gastritis is the timing of pain.

Diagnosis 52

Diagnosis Management IT Patient-Centered 52

Mesa Family Physician

JUNE 11, 2025

In this blog, we’ll break down what preventive care involves, explore its relationship with short-term health insurance, and explain why it’s a critical part of staying healthy at any stage of life. Preventive” is more commonly used in clinical and formal writing, while “preventative” is more casual. What Is Preventive Care?

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Illness Preventative Care Preventive Care Insurance 100

ABIM

JUNE 4, 2025

Representatives from the American Association of Clinical Endocrinology (AACE), the Association of Program Directors in Endocrinology, Diabetes and Metabolism (APDEM) and the Endocrine Society joined for a portion of the meeting*. Visit the ABIM Blog for reports of prior meetings. The following is a summary of the spring meeting.

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Diabetes Board-Certified Telehealth Government 52

GeriPal

JANUARY 18, 2024

In particular, we talk about Katie’s and Jesica’s paper in NEJM titled “ Juggling Two Full-Time Jobs — Methadone Clinic Engagement and Cancer Care ,” which described the difficulty in managing cancer pain and methadone for opioid use disorder. Panelists Katie Fitzgerald Jones and Jessica Merlin have no relationships to disclose.

Illness 137

Illness Patient-Centered Screening Clinic 137

GeriPal

FEBRUARY 29, 2024

Widera and Smith have no relationships to disclose. Guest hosts Lynn Flint and Anne Kelly have no relationships to disclose. 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. We were a blog?

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IT Patient-Centered Illness Education 127

GeriPal

SEPTEMBER 22, 2022

And I think also some of the stuff we’ll be talking about, when it comes to communication, I mean, a lot of the clinical encounter is listening to the music. Tell me about the clinical enc… How do you think the uncanny valley fits into medicine and communication training and skills? What is the uncanny valley? Eric: Yeah.

Illness 102

Illness IT Patient-Centered Patients 102

GeriPal

DECEMBER 8, 2022

Eric’s blog post on Dignity Therapy from 2011. Tell me how your illness has impacted your relationships with others, your healthcare team, your family, friends, your beliefs, your values, your preferences. Working with our clinical decision support team and thinking about where that could be. About us – Dignity in Care.

Patient-Centered 116

Patient-Centered Illness Healthcare IT 116

The Clinical Problem Solvers

MAY 30, 2022

Applying a critical race lens to relationship-centered care in pregnancy and childbirth: An antidote to structural racism. Health Affairs Blog. The Clinical Problem Solvers Podcast – Antiracism in Medicine Series. See Reference 20 below for additional information. References Hardeman RR, Karbeah J, Kozhimannil KB.

Community 52

Community Patient-Centered Families Family 52

GeriPal

DECEMBER 15, 2022

Tell me how your illness has impacted your relationships with others, your healthcare team, your family, friends, your beliefs, your values, your preferences. 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.

IT 106

IT Patient-Centered Healthcare Illness 106

FDA Law Blog

JUNE 4, 2025

Indications for chronic diseases do not generally reflect the length of the clinical trial; FDA determines that clinical trials supporting such approvals are of sufficient duration and makes an approval determination.

Chronic Disease 59

Chronic Disease Government Clinic Chronic Condition 59

GeriPal

MARCH 30, 2023

I started blogging as a patient, just talking about my own story online like patients did back in the day. I was like maybe I’ll write a blog post about this later. I’m going to try to remember as much as I can, so when I wake up, can I write a … My thought was I’m going to write a cool blog post about this.

IT 96

IT Patient-Centered Patients Healthcare 96

FDA Law Blog

JANUARY 8, 2023

Doctor-Patient Relationship. The Act requires that HHS provide a scientific analysis on whether cannabis and its derivatives are safe and effective treatments for different medical ailments and their other effects on the human body.

Medical 64

Medical Manufacturing Electronics Provider 64

Family Medicine Initiative

APRIL 10, 2024

This graph illustrates that the benefit of long-term GP-patient relationships is even dose-dependent (longer GP-patient-relationship = lower risk of dying prematurely): Why do long-term GP-patient relationships improve health and reduce costs? 11 , 13 Over time, GPs come to know their patients well.

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Family Physician Families Family GP 130

GeriPal

JANUARY 11, 2024

** Claim your CME credit for EP293 “What’s Up With MAID in Canada” [link] Note : If you have not already registered for CME, you can register here [link] For more info on the CME credit, go to [link] Disclosures: Moderators Drs Widera and Smith have no relationships to disclose. Bill, welcome back to GeriPal.

Illness 144

Illness IT Medical Provider 144

GeriPal

SEPTEMBER 19, 2024

Eric 07:31 A clinical perspective, why is it important to test this stepped care model versus implementing more? And now when I think about the clinic at Duke, when we’re really running on all cylinders, we can get ourselves up to a five, six, seven week wait for a new palliative care referral. This is Eric Widera.

Patient-Centered 120

Patient-Centered IT Patients Hospital 120

GeriPal

MARCH 20, 2025

Alex 00:48 And we’re delighted to welcome back Josh Briscoe, who’s a palliative care doc at the Durham VA Medical center in Duke and blogs at Notes from a Family Meeting. I was part of a writing group that wrote clinical guidelines for VSET for voluntarily stopping eating and drinking. Thaddeus 00:46 Thank you.

IT 89

IT Patient-Centered Patients Medical 89

GeriPal

APRIL 18, 2024

I remember walking through San Francisco Airport with Bob, we just happened to be there at similar times, and saying, “Eric and I are thinking about starting a blog.” And you say, “Okay, that’s fine, but can it really … What about a real live clinical situation?” That is the first clinical use case.

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IT Electronics Patients Healthcare 140

GeriPal

APRIL 11, 2024

This podcast was initially sparked by Josh’s “Note From a Family Meeting” Substack post titled “ Ambivalence in Clinical Decision-Making ,” which discussed Bryanna’s and Jenny’s 2022 article titled “ Two Minds, One Patient: Clearing up Confusion About Ambivalence.” Widera and Smith have no relationships to disclose.

Patient-Centered 129

Patient-Centered IT Patients Consulting 129

GeriPal

APRIL 26, 2024

Widera and Smith have no relationships to disclose. Guest Betty Ferrell has no relationships to disclose. Alex: We are delighted to welcome Bryanna Moore, who is a philosopher and bioethicist, and she’s at the University of Texas Medical Branch where she also directs the clinical Ethics Fellowship. Bry: Yeah, Eric.

Patient-Centered 121

Patient-Centered IT Patients Consulting 121

GeriPal

DECEMBER 12, 2024

Does this issue ring true to you clinically? In your clinical, everyday reality, this comes up and say, like, does this ring true to you from your work in the icu, from your work with patients? It’s going to be really hard psychologically for the clinical team, the surrogate, to override that default. You’re in it.

Patient-Centered 110

Patient-Centered IT Patients Healthcare 110

FDA Law Blog

NOVEMBER 8, 2022

Torres also shared that the eSTAR program, which we most recently blogged about here , is being developed with Health Canada. To paraphrase from our blog post , EUAs are triggered by an EUA declaration; FDA will publish advanced notice for an EUA declaration and provide a 180 day notice before the implementation of the transition plan.

Medical 59

Medical Manufacturing Patient-Centered Provider 59