FDA Law

JULY 24, 2023

This time, rather than use codes and patent certifications, the fight is over orphan drug exclusivity (“ODE”), with Jazz challenging FDA’s clinical superiority decision concerning sodium oxybate in the treatment of narcolepsy. 360cc(c), the statute does not permit FDA to promulgate regulations to use clinical superiority to break ODE.

Clinic 52

Clinic Provider IT Patients 52

FDA Law

JANUARY 18, 2022

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. complaint handling and adverse event reporting processes) and staff trained in the maintenance of equipment.

Medical 98

Medical Manufacturing Healthcare Government 98

FDA Law

JANUARY 5, 2023

But a compromised device is a threat to patient safety, so that timeline that could change in the event of an adverse event that imperils consumer health. Until that happens, interested parties in this space continue to face many of the same cybersecurity threats as other data-tech entities.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 59

FDA Law

JANUARY 18, 2022

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. complaint handling and adverse event reporting processes) and staff trained in the maintenance of equipment.

Medical 75

Medical Manufacturing Healthcare Government 75

FDA Law

JANUARY 12, 2025

Background on Accelerated Approval The key concept, an ingenuity of FDA itself that has been around since the beginning of accelerated approval, is to allow earlier access to a promising therapy for a serious condition with an unmet medical need based on an endpoint that is reasonably likely to predict clinical benefit.

Clinic 64

Clinic Relationship Provider IT 64

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

FDA Law

JUNE 9, 2025

These events marked a turning point in expanding representation in clinical studies and opening the door to more personalized medical care. Since 1993, Congress has continued to direct the federal government, and in particular FDA, to take steps to close the gap in clinical research representation.

Clinic 59

Clinic IT Healthcare Medical 59

FDA Law

JUNE 4, 2025

Ordinarily, a public health initiative of such magnitude would have been governed by a transparent multi-step process featuring public meetings and drawing on external scientific expertise. In other words, as you read this, the Assessments findings and recommendations are getting baked into federal government policy, for better or worse.

Chronic Disease 59

Chronic Disease Government Chronic Condition Clinic 59

GeriPal

OCTOBER 20, 2022

For the policy buffs and policy newbies out there, we hope this podcast is an essential primer to government in action. There’s the complications associated with immune senescence, comorbidities, atypical clinical presentations. We talk about: . The structure of federal agencies and how they coordinate. difficile infections.

Complication 52

Complication Patient-Centered IT Patients 52

GeriPal

MARCH 16, 2023

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. In clinic, I’m helping what, hundreds or thousands. Talent is something, but it’s really about putting in the work and then keeping also to place it somewhere or waiting for an event.

IT 104

IT Healthcare Professional Healthcare Transportation 104

GeriPal

JULY 6, 2023

I think to some extent, the county doesn’t necessarily know what they don’t know about geriatrics, just like I don’t necessarily know what I don’t know about the county and local government and national government and state government. And then, the system responds in turn.

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

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. Perhaps most notable in yesterdays argument, though, was what didnt happen.

Patient-Centered 102

Patient-Centered Consulting Government Clinic 102