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 These AI requests often address complicated scientific scenarios in which a submitter has already provided some information, but FDA is not completely satisfied. Average Number of Industry Days to MDUFA IV Decision 54.69

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Provider IT Engineering Medical 75

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.

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IT Patients Individual Provider 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). This is Eric Widera. Tamryn: Yes, 100%.

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Diabetes Management Patient-Centered Families 74

The Clinical Problem Solvers

FEBRUARY 8, 2023

One example that is presented involves the complicated relationship between the United States and Chinese immigrants and farmworkers in California. Dr. Jordan then questions the utility and continued operation of methadone clinics, especially as the United States largely moves on from the COVID-19 pandemic.

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Community Patient-Centered Mental Health Board-Certified 52

GeriPal

SEPTEMBER 7, 2023

Based on this surge in evidence, the American Society of Clinical Oncologists recently updated their guidelines for care of older adults to state that all older adults receiving systemic therapy (including chemo, immuno, targeted, hormonal therapy) should receive geriatric assessment guided care. Mazie, welcome to GeriPal. William: Sure.

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Patient-Centered IT Patients Clinic 130

GeriPal

OCTOBER 24, 2024

Summary Transcript CME Summary Cannabis is complicated. And then I met a patient in clinic once who asked me a lot of really intelligent questions about medical cannabis, what it does. I’d been a nurse at the time, and I went back to do my clinicals in an oncology clinic locally. They just kept at it.

Medical 100

Medical IT Patient-Centered Healthcare 100

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

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. Love to talk about also in the serious illness population. I’m going to first turn to Emmy.

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IT Families 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? More and more people have been having to call 911 for falls and they’re not able to get up. So we’ve published a couple of studies ourselves and we’re finding more and more groups that are trialing in different capacities.

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Community Transportation IT PCP 116

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. GPs improve chronic disease management, which prevents complications.

Family Physician 130

Family Physician Families Family GP 130

GeriPal

MARCH 3, 2022

I want to say like 2017, 2018, something like that. I think it’s really, really complicated. Julien: When I closed my eyes, I actually thought this is an actual recording of Chris Cornell. It was amazing. It was really, really crazy. Alex: When did he die? Eric: A while back, right? Julien: Four years ago. Alex: Yeah. Really sad.

Patient-Centered 96

Patient-Centered Patients IT Hospital 96

GeriPal

MARCH 27, 2025

Summary Transcript CME Summary A pragmatic trial evaluates the effectiveness of a treatment or intervention in real-world clinical practice. But the process of implementing this project across two big health systems in our area was very complicated and had its share of both challenges and rewards. We did it by the clinic level.

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Primary Care IT Clinic Patient-Centered 80

GeriPal

FEBRUARY 24, 2022

Should we focus on something else, both from a clinical and a research perspective? And I think the advanced planning debate is really a question of, how do we help this very complicated situation? Like, should we be doing advance care planning? What’s the evidence behind it? Should we throw it out? We see how hard it is.

Illness 98

Illness Patient-Centered IT Patients 98

Pamela Wible MD

JUNE 19, 2025

Drawing from her experience running a physician suicide helpline , she speaks candidly about the emotional toll of assembly-line medicine , the link between overwork and doctor suicide , and the revolutionary joy of reclaiming your career by launching your own ideal clinic. I was in a big-box clinic. Does that make any sense at all?

Clinic 246

Clinic Nurse Practitioner IT Medical 246

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.

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IT Vaccination Diagnosis Complication 52