FDA Law

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

Manufacturing 59

Manufacturing Engineering Clinic Provider 59

GeriPal

JUNE 20, 2024

It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. George 03:01 So I would say that as many clinical issues in older adults, we need to think about them in two ways. Eric 11:57 In, let’s say, my clinic. Eric 08:05 Yeah.

IT 120

IT Patient-Centered Patients Clinic 120

GeriPal

MAY 5, 2022

Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? Lastly, I also just want to give a shout out to the last article above which also includes this lovely checklist of methods to address hearing loss in clinical encounters. I’m guessing not. Transcript.

IT 102

IT Screening Hospital Clinic 102

FDA Law

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 1] However, the focus of CLIA requirements is on laboratory processes, not specific assays.

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

FDA Law

OCTOBER 16, 2024

There, as we explained back in July , Novartis argued that FDA’s approval of a generic ENTRESTO with indication information modified rather than simply omitted “represents a sharp departure from FDA’s statutory and regulatory mandate to require that a generic drug be the ‘same’ as its reference listed drug.”

Manufacturing 98

Manufacturing Patients IT Hospital 98

The Clinical Problem Solvers

NOVEMBER 6, 2023

Identify ways to navigate clinical interactions with patients while respecting them and affirming their experiences with food and fatness. Physical Fitness.” Anti-Blackness, Anti-Fatness, and Food Shaming” The Clinical Problem Solvers Podcast – Antiracism in Medicine Series. is rooted in anti-Blackness. Time Magazine.

Community 52

Community Manufacturing Patients Medical 52

GeriPal

MAY 8, 2025

We’ll discuss three recent clinical trials involving patients with serious illness, joined by our guests James Downar , Ali John Zarrabi , and Margaret Ross. Alex 00:33 Our next guest is Margaret Ross, who’s a clinical psychologist and researcher at St. Dr. James, welcome to the GeriPal Podcast. James 00:32 Good afternoon.

Illness 107

Illness IT Patient-Centered Patients 107