FDA Law Blog

MAY 8, 2023

The discussion paper described a PCCP as including (1) the types of anticipated modifications (SaMD Pre-Specifications or SPS) based on the retraining and model update strategy and (2) the associated methodology (Algorithm Change Protocol or ACP) being used to implement those changes in a controlled manner to manage patient risks.

Manufacturing 98

Manufacturing Provider Medical IT 98

FDA Law Blog

MAY 27, 2024

Jennifer’s return adds depth and breadth to our device practice and her strong relationships from her earlier time at the firm has made for a seamless reentry,” said J.P. Ellison, Managing Director at HPM. She also specializes in medical device software and digital health.

Manufacturing 59

Manufacturing Management Utilities Relationship 59

Physician's Practice

JUNE 9, 2025

Financial Relationships with Pharmaceutical Companies (00:20:10)** Legal and ethical concerns for physicians with financial ties to GLP-1 drug manufacturers, including anti-kickback laws. 68: Hidden risks of prescribing GLP-1 drugs with Ericka L. 68: Hidden risks of prescribing GLP-1 drugs with Ericka L. Adler, J.D.,

Management 52

Management Telemedicine Insurance Patients 52

GeriPal

JUNE 20, 2024

Widera and Smith have no relationships to disclose. Guests George Kuchel & Alison Huang have no relationships to disclose. Is there any relationship between frailty and urinary incontinence? We think of it really as a kind of a management tool as well. I don’t see those perspectives as incompatible.

IT 120

IT Patient-Centered Patients Clinic 120

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. Livornese and Josephine M. Notable Dates and Timelines – New MAPP published, by Dec.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

The Clinical Problem Solvers

NOVEMBER 6, 2023

Between the years 2019 and 2021, Harrison served as Associate Editor—and later as Managing Editor—of Wear Your Voice Magazine. All of this contributes to various mental health challenges that are consistent with surveillance in not only a wider police-state but also the patient-physician relationship. Williams-Forson and Da’Shaun L.

Community 52

Community Manufacturing Patients Medical 52

GeriPal

MAY 8, 2025

Alex 06:03 Is psilocybin that’s used for medicinal purposes in your studies, for example, is that manufactured or is it derived directly from mushrooms? And those of us who work in palliative care are more familiar with the 5ht3 receptor, which we use for nausea management. So I can say anything I want. So 5ht2 was. I love that.

Illness 107

Illness IT Patient-Centered Patients 107