FDA Law

JANUARY 18, 2022

The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. The regulatory requirements for the devices that are 3D-printed generally govern the responsibilities of the entities that are manufacturing and distributing the 3D printing equipment for that use at the point of care.

Medical 98

Medical Manufacturing Healthcare Government 98

FDA Law

JANUARY 5, 2023

Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well. By John W.M.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 59

FDA Law

JANUARY 12, 2025

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. an intermediate clinical endpoint) and that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.

Clinic 64

Clinic Relationship Provider IT 64

FDA Law

JANUARY 18, 2022

The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. The regulatory requirements for the devices that are 3D-printed generally govern the responsibilities of the entities that are manufacturing and distributing the 3D printing equipment for that use at the point of care.

Medical 75

Medical Manufacturing Healthcare Government 75

FDA Law

AUGUST 4, 2022

The approval process, pre-approval concerns, product labeling, clinical trials, adverse events reports, patent concerns, and exclusivity – these are all critical aspects in the commercialization process for drugs and biologics that are governed by the FDA.

Government 40

Government Clinic Individual Provider 40

GeriPal

OCTOBER 20, 2022

This office is tasked with providing aging policy research and recommendations within ASPE, including long term care and the National Alzheimer’s Project Act. For the policy buffs and policy newbies out there, we hope this podcast is an essential primer to government in action. We talk about: . difficile infections.

Complication 52

Complication Patient-Centered IT Patients 52

GeriPal

JULY 6, 2023

It was designed to really balance what Medicaid at the time was to provide nursing homes and Medicare is obviously health insurance. The long-term care is being actually provided in the community at a much higher rate than what the formal system provides. But, what you need is a community-based game there.

Community 89

Community Nurse Practitioner Provider IT 89

GeriPal

DECEMBER 7, 2023

AlexSmithMD Additional links: JAMA paper on clinical research risks, climate change, and health Geriatric medicine in the era of climate change Health Care Without Harm: [link] Practice Green Health: [link] Global Consortium for Climate and Health Education: [link] Transcript Eric: Welcome to the GeriPal podcast.

Healthcare 128

Healthcare IT Education Community 128

GeriPal

MARCH 16, 2023

So this week we’re going to be talking about writing for the lay public, and next week we’ll be publishing a podcast on writing for healthcare providers. And then I feel like when I’m in clinic I’m helping individuals, and you only have so much time to help so many people. Rosanne: I certainly do.

IT 104

IT Healthcare Professional Healthcare Transportation 104

GeriPal

APRIL 20, 2023

I would talk about this, except I was a clinician, and I’m seeing these folks in the hospital and in clinic. The journal section’s requirements are the same as for a clinical investigation. Folks who were first homeless after 50, there was an event, and usually those events could be described in one of four categories.

Mental Health 122

Mental Health Community IT Individual 122

FDA Law

FEBRUARY 20, 2025

On February 19, 2025, Judge Sean Jordan in the Eastern District of Texas heard oral arguments in American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathologys (AMP) [1] lawsuit against the Department of Health and Human Services. The LDT Rule itself provides no operational guidance, but only a definition.

Patient-Centered 102

Patient-Centered Consulting Government Clinic 102