FDA Law Blog

JULY 5, 2023

Outsourcing facilities are not exempt from FDA’s cGMP for drug manufacturers (as lightly tweaked via cGMP Guidance for outsourcing facilities ) or adverse event reporting requirements , and are subject to regular inspection by FDA. Section II at 2.

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Supply Chain Manufacturing Physicals Healthcare 52

Physician's Practice

JUNE 9, 2025

a health care attorney with Roetzel & Andress, joins the show to explore the legal risks of prescribing GLP-1 medications. 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. Adler, J.D.,

Management 52

Management Telemedicine Patients Insurance 52

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. If FDA accepts the application, the sponsor can then submit their supplement in two parts.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

GeriPal

MAY 5, 2022

But when you talk to people about relationships, the fact that they’re trying to communicate at church or any kind of house of worship, or go out to meetings, the fact that people stop going out to events, that they restrict what they’re doing. Hearing aids, you had six big manufacturers of hearing aids.

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IT Screening Hospital Clinic 102

FDA Law Blog

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. All of this contributes uniquely to social death.

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 Blog

JUNE 4, 2025

However, as the Assessment notes, [t]here aremany possible adverse events for which there is inadequate evidence to accept or reject a causal relationship, which may otherwise lead manufacturers to opt not to include them in the labeling.

Chronic Disease 59

Chronic Disease Government Clinic Chronic Condition 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.

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FDA Law Blog

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).

Medical 59

Medical Manufacturing Patient-Centered Provider 59

FDA Law Blog

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.

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