Physician's Practice

JUNE 9, 2025

a health care attorney and practice group manager with Roetzel & Andress, joins the show to break down the hidden legal risks of prescribing GLP-1 medications that physicians need to know about, from ensuring informed consent to navigating long-term safety data. Adler, J.D.,

Management 52

Management Telemedicine Patients Insurance 52

FDA Law Blog

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

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. §

Patient-Centered 52

Patient-Centered Healthcare Manufacturing 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. It’s because they literally couldn’t access the information. Hearing aids, you had six big manufacturers of hearing aids. Five big manufacturers. So they’re left out. Eric: Great.

IT 102

IT Screening Hospital Clinic 102

The Clinical Problem Solvers

NOVEMBER 6, 2023

Harrison, the work that they do is deeply informed by the history of chattel slavery in the United States, through which eugenicists, white anthropologists, and racial realists created entire disorders to medicalize and bastardize enslaved folks who were interested in freedom. Episode Takeaways Origin Stories – For Dr. Psyche A.

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. With respect to timing, DEA must issue a registration or request supplemental information within 60 days after receiving a complete application.

Medical 64

Medical Manufacturing Electronics Provider 64

FDA Law Blog

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

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? Eric 24:59 Have to release any embargoed information with us. So I can say anything I want.

Illness 107

Illness IT Patient-Centered Patients 107

GeriPal

DECEMBER 7, 2023

Nursing’s had a problem getting it there, and we may get there at some point, but medicine is working on that, and there’s an organization called Global Consortium for Climate and Health Education that is really leading the way for all healthcare providers for information on how to do that. Karl: Sure.

Healthcare 129

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

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. A pre-enforcement challenge is not the only option, of course.

Manufacturing 59

Manufacturing Provider Medical IT 59