FDA Law Blog

JULY 17, 2024

This individual will play a key role in overseeing the new integrated Hub model and helping to develop and implement its strategic agenda action plan. clinical pharmacology/biomarkers, animal models, real-world evidence and other externally controlled comparisons [e.g.,

Patient-Centered 105

Patient-Centered Community Medical Specialty Clinic 105

The Clinical Problem Solvers

JANUARY 18, 2021

Understand that collective action and a focus on community, rather than individualism, are most effective in combating racism and achieving health equity. One of the biggest barriers to health equity is the narrow focus on the individual and a failure to see health as a widespread community issue. The Clinical Problem Solvers Podcast.

Community 52

Community Medical Individual IT 52

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

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).

Lab Testing 52

Lab Testing Referral Individual Patient-Centered 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).

Lab Testing 40

Lab Testing Individual Referral Patient-Centered 40

PEMBlog

OCTOBER 18, 2024

The condition affects multiple organ systems—muscular, cardiac, and respiratory—leading to a myriad of clinical complications. Always review the latest care plans, assess longitudinal trends in cardiac biomarkers, and consult with specialists when needed to ensure that each patient receives individualized and optimal care. 2018-0333I.

Patients 52

Patients Complication Management Consulting 52

GeriPal

MAY 19, 2022

It depends on the clinical situation. But we still, regardless of how you do this calculation have to temper it with clinical judgment. Mary Lynn: I’m willing to bet that you temper that calculation with your clinical judgment though. And then again, individualizing it to the patient. Eric: All right. Eric: Yeah.

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IT Patients Individual Relationship 139

The Clinical Problem Solvers

AUGUST 25, 2020

Pearls Defining Structural Racism Structural racism is a term that acknowledges that racism is perpetuated beyond individual interactions and interpersonal racism, but is present in the systems and policies that govern our everyday lives. Essien, MD, MPH Hosts: Dereck Paul, MS, Utibe R. N Engl J Med 2020; 383:197-199.

Community 52

Community Patient-Centered Relationship Education 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., randomization, blinding).” Fiscal Year. Total Requests Received. Granted .

IT 52

IT Clinic Provider Medical 52

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

Pamela Wible MD

JUNE 20, 2025

During that time, psychologist Herbert Freudenberger volunteered at a New York City free clinic treating addiction. He overheard the term and used it to describe himself and clinic staff in a 1974 article on staff burnout detailing long-term physical and psychological job stress. So what’s the real issue?

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Medical Student Diagnosis Physicals Medical 246

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 if additional testing is required or justification would suffice), responsible individuals, proposed timelines, and any clarifying questions for FDA. Average Number of Industry Days to MDUFA IV Decision 54.69

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Provider IT Engineering Medical 75

FDA Law Blog

SEPTEMBER 20, 2021

The sponsor then gets the review ball rolling by submitting all of the efficacy supplement minus the final clinical study reports and clinical summaries. based upon the anticipated clinical benefit of earlier patient access to the product.”. Notable Dates and Timelines – Applications open, Q4 of FY 2023.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law Blog

MAY 17, 2022

FDA approved FIRDAPSE in November 2018, with a period of orphan drug exclusivity, for the treatment of Lambert-Eaton Myasthenic Syndrome (“LEMS”) in adult patients. But in May 2019, FDA approved a second amifampridine drug product, Jacobus Pharmaceutical Company, Inc.’s and more likely 15-20.

IT 40

IT Patients Provider Individual 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. If in your own work, your clinical work, is this something that you see people struggle with you, you see yourself struggle with? Goldilocks zone). Eric: Let me ask you a question.

Diabetes 74

Diabetes Management Patient-Centered Families 74

FDA Law Blog

JUNE 16, 2023

The statute confuses the issue by providing that “every individual transaction in violation of [the excessive price increase prohibition] is considered a separate violation,” making it unclear whether this is a per-day or per-transaction penalty, and, if the latter, what the transaction is.

Manufacturing 45

Manufacturing Provider Consulting IT 45

Physician's Weekly

JUNE 19, 2025

Independent Association The study involved analysis of data from 43,842 adults in the National Health and Nutrition Examination Survey (NHANES, 1999-2018). Clinical Implications “Higher DII is independently associated with an increased risk of CHD, potentially through pathways involving metabolism, lipid levels, and kidney function.

Hypertension 52

Hypertension Individual Diabetes Diagnose 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

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.

Medical 53

Medical Diagnosis Healthcare Clinic 53

GeriPal

FEBRUARY 6, 2025

So let’s just say you have a healthy 55 year old or 65 year old in your clinic. So whether it’s 50, 52, 55, 65, we should ask every person who comes into clinic at least once a year, how do you feel like your thinking is? So I’m in a specialty clinic, so I’m in this interdisciplinary memory assessment clinic.

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Primary Care Diagnosis Screening IT 97

GeriPal

AUGUST 17, 2023

Praised by the FDA, Alzheimer’s Association (AA), and Pharma as a “game changer”, but derided by others for the drug’s lack of clinical efficacy, risk of severe adverse effects, absence of diversity in trial populations, high costs, and an FDA approval process that was in the kindest words “rife with irregularities”. I’m a prescriber.

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Patient-Centered IT Clinic Patients 98

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. I also heard that if you look at all individuals in the US, about 4% of individuals are taking one of the gabapentinoids, 10% over 65.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

GeriPal

JULY 21, 2022

I don’t practice clinically in outpatient settings, and often the folks I’m seeing are there for other kinds of issues. Eric: For those of you don’t know, Emmy was on our podcast back in 2018 … man, pre-COVID times. That’s where it really gets to this individual risks and balances, individual situation.

Families 102

Families IT Family Diagnosis 102

GeriPal

FEBRUARY 15, 2024

Eric: So you both published a paper in JAGS, what, 2018, ’19 looking at what happens to people? All of these are factors that are on the individual level. More and more people have been having to call 911 for falls and they’re not able to get up. Same thing with kind of medication management.

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Community Transportation IT PCP 116

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.

IT 65

IT Hospital Screening Patients 65

The Clinical Problem Solvers

MAY 30, 2022

She urges us to recognize that maternal mortality changes the life trajectories of individuals and communities. The Clinical Problem Solvers Podcast – Antiracism in Medicine Series. Kozhimannil reminds us to look past the statistics and zoom into the personal level. The practice of midwifery in rural US hospitals. May 31, 2022.

Community 52

Community Patient-Centered Families Family 52

GeriPal

MARCH 24, 2022

2018 Systematic Review of Systematic Reviews on ACP. 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. Alex: What did it changed to after 2018? We can work it out! AlexSmithMD. Transcript.

Illness 73

Illness IT Healthcare Patient-Centered 73

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. There are clinics. Alex: A few years back.

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Families Family IT Community 133

GeriPal

MARCH 3, 2022

I want to say like 2017, 2018, something like that. Lauren: Although again, still thinking about what that means for an individual older adult is really important. Julien: But every time we look at one of these individual interventions, we’re not always seeing what we want to see. It was amazing. Alex: When did he die?

Patient-Centered 96

Patient-Centered Patients IT Illness 96

GeriPal

APRIL 24, 2025

We and our guests have noticed that in our clinical practices, patients and caregivers seem to be asking for such treatments more frequently. Eric 06:58 It could be CPR in an individual with metastatic cancer in the icu. And in addition, my work in palliative care, I also am a clinical ethicist. Ivermectin to treat cancer.

Patient-Centered 79

Patient-Centered IT Patients Illness 79

GeriPal

OCTOBER 3, 2024

How the act of drawing can help us sloooow down, pay attention to the people and world around us, and ultimately let go… The possibility of incorporating drawings in research and even clinical care. I cracked myself in my head of these individuals. Frank, welcome to the GeriPal podcast. I was going to say illustrations.

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IT Patient-Centered Patients Relationship 123

Family Medicine Initiative

APRIL 10, 2024

million people in 2018), shows that the longer you know your GP, the better off you are. On average, twice as many patients have contact with GPs than with all specialists (in offices and/or outpatient clinics) combined. of healthcare costs in the EU 2018. A fantastic study from Norway 12 (based on 4.5

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Family Physician Families Family GP 130

GeriPal

MARCH 27, 2025

Summary Transcript CME Summary A pragmatic trial evaluates the effectiveness of a treatment or intervention in real-world clinical practice. Eric 08:37 And that’s because you randomized clinics, you didn’t randomize patients interventions. We did it by the clinic level. And so everyone who’s in that clinic was.

Primary Care 80

Primary Care IT Clinic Illness 80

PEMBlog

DECEMBER 4, 2024

We will review the clinical presentation, diagnostic strategies, management protocols, infection control practices, and vaccination updates. Learning Objectives Understand the clinical progression of pertussis through its three distinct stages and identify key symptoms, including age-specific presentations in infants and older children.

IT 52

IT Vaccination Diagnosis Complication 52

FDA Law Blog

SEPTEMBER 13, 2021

In 2018, Trump’s Department of Health and Human Services (HHS) released its Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs , but the edifice envisioned by the Blueprint largely failed to materialize. Drug Price Negotiation to Benefit Medicare and Commercial Plans.

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Manufacturing Supply Chain Patient-Centered Utilities 98