FDA Law Blog

SEPTEMBER 11, 2023

The electronic Submission Template and Resource (eSTAR) program, which we blogged about here and here , also makes the highlight reel given its aim to improve consistency and efficiency in how 510(k)s are prepared.

Medical 64

Medical Electronics Manufacturing Utilities 64

FDA Law Blog

AUGUST 29, 2021

This policy, announced by then Associate Attorney General Rachel Brand in 2018 was referred to as the Brand Memo. electronic formatting for regulatory submissions), scientific (e.g., clinical testing of implanted brain computer interface devices for patients with paralysis or amputation), enforcement (e.g.,

Government 52

Government Electronics IT Clinic 52

FDA Law Blog

NOVEMBER 20, 2024

Exhaustive extraction in these solvents can lead to high levels of product degradation or increased levels of extractables found in the chemical data, which is not expected during clinical use, and can often result in a TRA with a negative or inconclusive outcome.

Provider 59

Provider Medical Manufacturing Consulting 59

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 Team meetings with subject matter experts can be scheduled to discuss response strategies for deficiencies that require extensive clinical, scientific, or engineering input. 510(k) Time to MDUFA IV Decision.

Provider 75

Provider IT Engineering Medical 75

Annals of Family Medicine

NOVEMBER 20, 2024

Setting or Dataset: American Family Cohort, a data asset including electronic health records of 8 million patients from family practices across 50 US states. Population Studied: Patients with ≥1 visit between January 2018 and December 2019 and who remained in the cohort until at least May 2020. Measurements.

Primary Care 130

Primary Care Patients Diagnosis Family Practice 130

Annals of Family Medicine

NOVEMBER 20, 2024

The exposure was COVID-19 era (pre = March 10, 2018-March 10, 2020; during = March 11, 2020-March 11, 2022). Setting: Electronic Medical Record data from primary care clinics in the University of Toronto Practice Based-Research Network Data Safe Haven and Northern Ontario School of Medicine Research Toward Health Hub (Ontario, Canada).

Primary Care 130

Primary Care Electronics Clinic Medical 130

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.

Patient-Centered 129

Patient-Centered IT Patients Clinic 129

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. Or have electronic health record prompts so people remember to ask it?

Families 102

Families IT Family Diagnosis 102

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 79

Primary Care IT Clinic Illness 79

GeriPal

JULY 13, 2023

Summary Transcript Summary Today’s podcast is a follow up to our 2018 podcast with Randy Curtis about the Jumpstart intervention. And I think that his research was informed by his clinical practice, his clinical practice was informed by his research. So what’s changed since 2018 with Jumpstart? Erin: Mm-hmm.

Patient-Centered 84

Patient-Centered IT Hospital Patients 84

GeriPal

FEBRUARY 24, 2022

Should we focus on something else, both from a clinical and a research perspective? And so the definition of advance care planning really switched in, I think, 2017, 2018, there was kind of a United States definition and then an international consensus definition. Like, should we be doing advance care planning? Should we throw it out?

Illness 98

Illness Patient-Centered IT Families 98

Physician's Weekly

JUNE 25, 2025

“There’s no question that health insurers have a reputation problem,” said Robert Hartwig, an insurance expert and a clinical associate professor at the University of South Carolina. He noted that health insurers made “past promises” to improve prior authorization in 2018.

Insurance 52

Insurance Patient-Centered Government Patients 52