FDA Law Blog

OCTOBER 14, 2021

Given these onerous requirements, it is not a surprise that RAS device manufacturers have not sought clearance for RAS devices for oncology procedures. It would also be beyond the scope of what RAS device manufacturers are intending to offer, which is a better surgical tool, not a therapeutic for cancer. 21 U.S.C. §

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Patient-Centered Healthcare Manufacturing Provider 52

FDA Law Blog

SEPTEMBER 6, 2022

Two of the new questions added in the Draft Guidance (Q22 and Q23) address the fact that monitoring and other administrative “startup” costs, and manufacturing costs are often higher in the first year compared to subsequent years. These new Q & As explain that some sponsors may amortize costs.

Clinic 52

Clinic Manufacturing Patients IT 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? Most of the trials that have been conducted are conducted by the manufacturers of those medications.

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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

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.

Management 52

Management Telemedicine Patients Insurance 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

The Clinical Problem Solvers

NOVEMBER 6, 2023

The developing attitudes about food scarcity and deficit models, and mass media’s manufacturing consent, has to be challenged, especially because there is a deep and rich history of Black people as farmers, gardeners, and ranchers that belies what Chimamanda Ngozi Adichie calls the danger of a single story.

Community 52

Community Manufacturing Patients Medical 52

FDA Law Blog

JANUARY 8, 2023

Doctor-Patient Relationship. The Act mandates that DEA streamline and accelerate registration application procedures for cannabis researchers and manufacturers of cannabis for research. Cannabis Manufacturer Registration for Research. Cannabis Researcher Registrations. Application Process. 21 U.S.C. §

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Medical Manufacturing Electronics Provider 64

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.

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Chronic Disease Government Clinic Chronic Condition 59

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? So when they do meet it, how are you going to be in relationship to it? So I can say anything I want. I am not sticking my foot in my mouth. James 06:13 So I think in most cases.

Illness 107

Illness IT Patient-Centered Patients 107

GeriPal

DECEMBER 7, 2023

And so if we think of that relationship though, as these kinds of disasters increasing, so flooding, hurricanes, extreme heat and extreme cold, there are system level things to do. What’s our role in changing the healthcare system, in our own healthcare system. I mean, you are talking about a huge, huge network.

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Healthcare IT Education Community 129

FDA Law Blog

NOVEMBER 8, 2022

If you have a good relationship with the review team, Dr. Maisel encourages a brief phone call or quick email to obtain informal feedback. In closing, he advised manufacturers who plan to market their products beyond the public health emergency to plan to submit marketing applications.

Medical 59

Medical Manufacturing Patient-Centered Provider 59

FDA Law Blog

MAY 26, 2025

The memos suggested use of the FDC Act to investigate and prosecute misbranding by manufacturers may have precedent, but a misbranding charge against a practitioner who uses drugs or other products in gender-affirming procedures would be subject to multiple legal challenges. A pre-enforcement challenge is not the only option, of course.

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Manufacturing Provider Medical IT 59