FDA Law

SEPTEMBER 20, 2021

requesting records in lieu of an inspection, use of information shared by trusted foreign regulatory partners). 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.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

GeriPal

MAY 5, 2022

And when you think about that, they’re hearing pieces of the information and their brain is trying to make sense of it. One thing we’ve looked at a little bit, but it has not been well studied is the accumulation of ototoxic medications. It’s because they literally couldn’t access the information.

IT 102

IT Screening Hospital Clinic 102

FDA Law

JANUARY 8, 2023

The enactment of the Medical Marijuana and Cannabidiol Research Expansion Act (“the Act”) into law (Public Law 117-215) last month is a step in that direction. To date 39 states and the District of Columbia have legalized cannabis for medical use (and 21 for adult recreational use), mainly through ballot initiatives. 21 U.S.C. §

Medical 64

Medical Manufacturing Electronics Provider 64

The Clinical Problem Solvers

NOVEMBER 6, 2023

Harrison Time Stamps 00:00 Opening 00:45 Introductions 03:07 Guest Introduction 1 04:46 Guest Introduction 2 08:15 On the Intersection of Black, Fat, and Trans Communities and the Medical-Industrial Complex 13:35 History and the Racial Underpinnings of Food Shaming in the U.S. On one hand, we must not moralize food choices.

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? What made this trial, I would say, unique, is that you have a palliative care physician and nurse following people with medication tapering in order to be dosed. Like all of.

Illness 107

Illness IT Patient-Centered Patients 107

FDA Law

JUNE 4, 2025

The Assessment suggests that FDA may be viewing indication claims with greater scrutiny moving forward, either at the time of approval or after, when such information may be available. Known clinically relevant safety and effectiveness information is generally included in the label under current practices.

Chronic Disease 59

Chronic Disease Government Chronic Condition Clinic 59

GeriPal

DECEMBER 7, 2023

And it is going to affect, if it hasn’t already, our food quality, the food that’s available, our medications. There’s an issue with an extreme heat, the medications may lose its efficacy, and there’s certain medications that make someone more vulnerable to heat emissions- Eric: And the power outages that we see.

Healthcare 129

Healthcare IT Education Hospital 129

FDA Law

NOVEMBER 8, 2022

By Véronique Li, Senior Medical Device Regulation Expert — At the latest MedTech conference held in Boston, MA from October 24-26, we heard from FDA officials and industry representatives on a range of topics. Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF).

Manufacturing 59

Manufacturing Medical Patient-Centered Provider 59

FDA Law

MAY 26, 2025

Even if otherwise truthful, the promotion of off-label uses of hormones-including through informal campaigns like those conducted by sales reps or under the guise of sponsored continuing medical education courses-run afoul of the FDAs prohibitions on misbranding and mislabeling. 116(e) (emphasis added). See 21 U.S.C.

Manufacturing 59

Manufacturing Provider Medical General Practice 59