FDA Law Blog

FEBRUARY 28, 2022

address common questions and misconceptions about collecting and submitting to FDA patient engagement information regarding the design and conduct of a medical device clinical study.”. What would be the potential benefits if companies prospectively design medical device clinical studies with input from diverse patient advisors?

Patients 52

Patients Clinic Medical Patient-Centered 52

FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Interpretation of Statutory Criteria Under the Final Guidance. Medical information about a patient.

Clinic 52

Clinic Medical Provider Patients 52

FDA Law Blog

OCTOBER 11, 2022

For the past two years, CDER’s Guidance Agenda has included a spot for this eagerly anticipated guidance, tentatively titled ‘Meeting the Substantial Evidence Standard Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence’. Sasinowski & James E.

Clinic 61

Clinic Provider IT Patient-Centered 61

FDA Law Blog

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

FDA Law Blog

MAY 8, 2023

See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a) a) , and related guidance documents (e.g., here for a 510(k) device and here for a PMA device). The draft guidance follows the December 2022 enactment of the Food and Drug Omnibus Reform Act of 2022 (FDORA).

Manufacturing 98

Manufacturing Provider Medical IT 98

FDA Law Blog

JANUARY 6, 2022

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. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 24(b) (emphasis added). 18 U.S.C. § 24(b) (emphasis added).

Lab Testing 52

Lab Testing Individual Referral Patient-Centered 52

FDA Law Blog

JUNE 29, 2022

It explains that “FDA typically gives greater weight to trials that are conducted in larger populations, use a well-understood and widely accepted, well-constructed clinical endpoint, and incorporate certain design features (e.g., Both documents describe the process in two steps: the intent to rescind step and the rescinding step.

IT 52

IT Clinic Provider Medical 52

GeriPal

NOVEMBER 9, 2023

The initial RCT published on physician coaching in JAMA in 2019 showing that coaching improves quality of life. Summary Transcript Summary Coaching is in. When I was a junior faculty, coaching wasn’t a thing. We address: What is coaching? How does it differ from therapy? link] Transcript Eric: Welcome to the GeriPal podcast. Indeed, matey.

Board-Certified 110

Board-Certified IT Primary Care Referral 110

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

JANUARY 6, 2022

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. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 24(b) (emphasis added). 18 U.S.C. § 24(b) (emphasis added).

Lab Testing 40

Lab Testing Individual Referral Patient-Centered 40

FDA Law Blog

JULY 10, 2023

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 By Philip Won & Adrienne R. Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. But that is only the beginning.

Provider 75

Provider IT Engineering Medical 75

FDA Law Blog

MAY 17, 2022

But in May 2019, FDA approved a second amifampridine drug product, Jacobus Pharmaceutical Company, Inc.’s And with “must-pass” FDA legislation, comes a host of riders—pieces of FDA-related legislation not specific to UFA reauthorization, but that folks seek to get added to the UFA bill to address various issues and topics. Becerra.”

IT 40

IT Patients Individual Provider 40

The Clinical Problem Solvers

DECEMBER 20, 2021

Highlight how structural racism against Asian-Americans surfaces in clinical settings, and describe means of counteracting such structures. [link] CPSolvers: Anti-Racism in Medicine Series Episode 13: Centering Asian Americans: Racism, Violence, and Health Show Notes by Naomi F. Insufficient language services (i.e.,

Community 52

Community Patient-Centered Relationship Healthcare 52

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.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

GeriPal

MARCH 24, 2023

I think some individuals thought there was cherry-picking of stories that made it seem like hospice is this bad thing, that it’s taking advantage of vulnerable individuals and it didn’t talk enough about the good things that hospice does. And the big question, is hospice losing its way? Is it you, Ira? Alex: Great choice.

IT 114

IT Provider Patients Families 114

The Clinical Problem Solvers

APRIL 5, 2022

Push back against individual narratives that blame individuals for systemic injustice. Published April 5, 2019. January 18, 2019. The Clinical Problem Solvers Podcast. Our guests remind us to ask our patients about their housing status using non-judgmental and non-stigmatizing language. Rothstein, R. April 5, 2022.

Community 52

Community Patient-Centered Emergency Room Medical 52

GeriPal

MAY 18, 2023

Alex: And we’re delighted to welcome Todd Semla, who is a clinical pharmacist and associate professor at the Feinberg School of Medicine at Northwestern University. We’ve invited two members who helped update the criteria including Todd Semla and Mike Steinman. Alex: We’re having Beers. We’ll learn about that. Eric: Mike?

Medical 97

Medical IT Patients Clinic 97

The Clinical Problem Solvers

OCTOBER 11, 2021

individual bias or bigotry that leads to a failure to sell a home to a person of color) and personal choices ( e.g. Black people prefer to live among other Black people) is referred to as de facto segregation. These gaps are not a product of lifestyle choices, biology or individual behaviors. 2020;324(3):231-232. doi:10.1001/jama.2020.9289

Government 52

Government Community Education Individual 52

GeriPal

MARCH 9, 2023

FDA is considering approval, shifting away from Schedule I restrictions, paving the way for use in clinical practice. In our prior podcast with Ira Byock on psychedelics in 2019 we talked primarily about the potential of psychedelics. Legalization is moving forward in several states , following the lead of Oregon and Colorado.

Patient-Centered 91

Patient-Centered Community IT Medical 91

GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. James 00:32 Good afternoon.

Illness 107

Illness IT Patient-Centered Patients 107

GeriPal

MARCH 2, 2023

AFP 2019 Gabapentin for chronic neuropathic pain in adults. By 2015 that number increased to 4% of US adults. There are a lot of reasons that may explain the massive increase in use of these drugs. One thing is clear, it is not because people are using it for FDA approved indications. Cochrane Database of Systematic Reviews Review.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

GeriPal

FEBRUARY 27, 2025

Substance use disorder is one of those complex issues in which clinical practice is changing rapidly. Sach Kale set up an outpatient clinic focused on substance use disorder for patients with cancer. Do you need to be an addiction medicine trained physician to start such a clinic (no: Sach is not). What do they do?

Patients 73

Patients Clinic Patient-Centered Illness 73

GeriPal

NOVEMBER 2, 2023

I’ve seen this question come up a lot since finishing fellowship nearly two decades ago. Historically, answers generally lamented the ever increasing need for geriatrics without a corresponding growth in the number of specialists in the field. Mike, welcome to GeriPal. Mike: Great to be here. Alex: We’ll take any Warriors we can get.

Board-Certified 91

Board-Certified IT Community Medical Student 91

GeriPal

APRIL 13, 2023

Are there meaningful ways of assessing loneliness and social isolation in clinical settings and connecting patients with interventions? The Listening “EAR” approach that simplifies assessment of loneliness and social isolation in clinical settings, and other practical pointers. Welcome back, Ashwin. Alex: Great.

IT 99

IT Community Patient-Centered Medical 99

BMJ

FEBRUARY 8, 2021

The proximity to campus health clinics may also afford college students greater accessibility to healthcare providers for prescription medications such as stimulants which could end up being misused. Besides the risks to an individual, there are also population-level harms from normalizing certain harmful behaviors (e.g., 2019-1372.

Medical 40

Medical Holistic Care Healthcare Healthcare Professional 40

The Clinical Problem Solvers

MAY 30, 2022

She urges us to recognize that maternal mortality changes the life trajectories of individuals and communities. Published January 16, 2019. Published April 10, 2019. Published March 11, 2019. The Clinical Problem Solvers Podcast – Antiracism in Medicine Series. Published online August 2020. link] Katy B.

Community 52

Community Patient-Centered Families Family 52

Medical Xpress

JUNE 8, 2025

Long-term effects of pain in early life We collected data on the number of procedures, clinical exposures and sucrose doses from three NICUs across Canada. But as the findings from our Canadian study show, we urgently need research to improve long-term health outcomes for children born prematurely. Read the original article.

IT 53

IT Management Vaccination Medical 53

GeriPal

AUGUST 25, 2022

And yet, we know little about the clinical experience of people with dementia in hospice. Second, Hospice was originally designed for patients with advanced cancer, but the fastest growing admitting diagnosis is dementia. People with dementia make up about half of hospice admissions. But before we do, I think somebody has a song request.

Families 106

Families Family IT Patients 106

FDA Law Blog

JUNE 2, 2023

For 10 high-cost single source covered outpatient drugs selected annually by CMS, manufacturers would be required to respond to a so-called “price verification survey” by providing not only clinical and utilization information about the drug, but also costs of production, distribution, research, and marketing; revenue and profit; and ex-U.S.

Manufacturing 59

Manufacturing Vaccination Government Diagnosis 59

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.

Primary Care 40

Primary Care Clinical Practice Electronics Clinic 40

The Clinical Problem Solvers

MAY 2, 2023

Naweed Hayat, a child and adolescent psychiatry fellow at the University of California San Diego, who applies his own lived experience of resettlement to his clinical practice. Identify the role of trauma-informed, culturally-responsive care for refugee, asylee, and immigrant populations and how it can be operationalized in clinical practice.

Healthcare 52

Healthcare Provider Clinical Practice Clinic 52

PEMBlog

APRIL 4, 2025

The episode emphasizes thoughtful, individualized care in the context of rising vaccine hesitancy and declining immunization rates. Unfortunately, timely clinical question, what do we do with the UN or under vaccinated child who presents to the emergency department with fever? So what are we gonna go over in this episode? Interesting.

Vaccination 66

Vaccination Illness IT Clinic 66

GeriPal

APRIL 17, 2025

What a Wonderful World could be sung in irony at this moment. I hope we all take it literally, with the hope this podcast ends with. Alex Smith ** This podcast is not CME eligible. To learn more about CME for other GeriPal episodes, click here. Transcript Eric 00:00 Welcome to the GeriPal Podcast. It is a terrific book. Alex 02:07 Yeah, I love it.

IT 70

IT Community Government Management 70

FDA Law Blog

SEPTEMBER 13, 2021

A May 2019 CMS final rule that would have required drug TV advertisements to disclose the WAC of the drug was challenged by a group of pharmaceutical companies and vacated on statutory grounds by the D.C. Last Thursday, the U.S. The actual policy proposals read like a wish list. Below, we summarize the key proposals of the HHS plan.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98