FDA Law

OCTOBER 7, 2024

27, 2024), the plaintiff H&P challenged an FDA administrative complaint assessing a civil money penalty of $20,678 for H&P sale of an electronic cigarette without FDA authorization. By JP Ellison & Anne K. Walsh — It took only 3 months. Constitution’s Seventh Amendment right to a jury trial. See SEC v Jarkesy , 144 S.

Electronics 59

Electronics IT Government Clinic 59

GeriPal

JULY 19, 2024

Summary Transcript Summary The US Preventive Services Task Force (USPSTF) concluded back in 2000 that there is insufficient evidence to recommend for or against routine screening for dementia in older adults. Are there, though, populations that it may be helpful in, or should that change with the advent of the new amyloid antibodies? Should it?

Screening 120

Screening Primary Care Patient-Centered IT 120

33 Charts

OCTOBER 2, 2021

A few ideas: Stronger technology governance of MyChart messages We want to call the MyChart mushroom an Epic problem. Bob Wachter from UCSF had this to say on Twitter recently: We’re seeing huge uptick in in-box messages for MDs during Covid – now seems like biggest driver of MD burnout. Crucial that we fix this. How do we fix this?

Patients 75

Patients IT Provider Family Doctor 75

FDA Law

JANUARY 5, 2023

FDA counsels that, as is the case with any other electronic device, seemingly small, routine steps like software maintenance and updates are ways companies can address possible vulnerabilities that could lead to adverse events. Post-market, combination products potentially face the same enforcement scrutiny as single-entity medical devices.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 59

FDA Law

SEPTEMBER 17, 2023

Inside Building 66 Upon arriving at Building 66, all visitors must present government-issued photo identification for check-in. Additionally, recent visitors did not have to scan their identification cards through an electronic machine. During this time, CDRH moved from Webex to Zoom and gained experience with the virtual platform.

Screening 59

Screening Transportation Provider Electronics 59

FDA Law

MARCH 20, 2022

In recognition that hard copy communications are slower and more cumbersome, FDA recommends that firms use electronic communications, as they lay out the details of the electronic means here , to notify the public about recalls. Almost all recalls are conducted on a voluntary basis by the manufacturer. Product coding (e.g.,

Electronics 40

Electronics Manufacturing Provider IT 40

FDA Law

FEBRUARY 7, 2024

Also, a DEA Form 452 report must be electronically filed within 15 days after the order is shipped. According to the eBay settlement agreement, the government contends that from October 2015 to the present, eBay did not comply with any of “the CSA’s reporting and recordkeeping obligations” involving thousands of transactions.

Government 116

Government Electronics Education Individual 116

Medical Xpress

JUNE 16, 2025

This region governs essential behaviors like the circadian clock, sleep, energy balance , and feeding. This cluster of about 20,000 to 40,000 neurons functions like a central watch, coordinating the timing of body functions to follow the 24-hour day. But the NTU team discovered that it is far more complex.

Provider 109

Provider Complication Medical Diabetes 109

GeriPal

JUNE 19, 2025

Just today (June 17th) as we record this podcast: Ezra Klein released a wonderful interview with Sarah McBride , the first openly transgender member of congress A judge ruled that cuts to NIH grants focused on minority groups, including transgender people, were illegal and ordered the government to restore funding. Can you tell me about that?

Individual 82

Individual Community IT Chronic Condition 82

GeriPal

JANUARY 20, 2023

There have been multiple subsequent government reports on nursing home care, most recently was about eight, nine years ago from the OIG. He’s a geriatrician and Chair of Public Policy for the California Association of Long-Term Care Medicine. Welcome back to the GeriPal podcast, Mike. I hope I got that right. Mike: You got it right.

Finance 95

Finance Board-Certified IT Provider 95

GeriPal

SEPTEMBER 5, 2024

But before we go into all of that, I think, Bill, you have a song request for Alex. Bill 01:52 I do. Bill 01:53 Alex asked me for a song that was resonating in my head at the time, and it would be Guy Clark’s song, T he Cape. Eric 02:01 Why guy Clark’s the Cape? Bill 02:03 Oh, it’s a long story. I’ll make sure. Here we go.

Patients 98

Patients IT Patient-Centered Hospital 98

GeriPal

APRIL 18, 2024

We discuss, among other things: Findings that in several studies AI was rated by patients as more empathetic than human clinicians (not less, that isn’t a typo). Turns my concern about lack of empathy from AI on its head – the AI may be more empathetic than clinicians, not less. ” Eric: What was it called again, Wachter’s World?

IT 140

IT Electronics Patients Healthcare 140

GeriPal

JULY 6, 2023

Summary Transcript Summary You may have heard of Area Agencies on Aging, but do you really know what they do or how they do it? What about State Departments of Aging or state master plans for aging? Do you know how these agencies fit in with programs like Meals-on-Wheels or other nutritional support programs? Susan: It is my anthem.

Community 89

Community Nurse Practitioner Provider IT 89

GeriPal

AUGUST 15, 2024

I had fun trying to make a danceable version with electronic drums for the audio-only podcast. It’s both institutionalized racism where there are policies and practices by corporations, by government that create inequality. Maybe we’ll get some BTS followers to subscribe to GeriPal?!? Jessica, welcome back to GeriPal.

Mental Health 118

Mental Health Community Screening IT 118

Medical Xpress

JUNE 7, 2025

The company is working with governments and health groups in the U.K. None of the participants who received the injections got HIV. That early success helped boost Gileads stock by 73% over the past year, The Wall Street Journal reported. "We But Gilead says the shot should help expand the overall number of people using PrEP in both the U.S.

Vaccination 64

Vaccination Insurance Medical Diabetes 64

Physician's Weekly

JUNE 26, 2025

CDC vaccine safety officer Robert Chen built on VAERS to create the Vaccine Safety Datalink, which looks for evidence of vaccine harms in electronic health records. Kennedy Jr. forced him out in May. But for Dressen and others convinced the vaccines injured them, their experiences were symptomatic of a well-intentioned but flawed U.S.

Vaccination 52

Vaccination Patient-Centered Government IT 52

Physician's Weekly

JUNE 25, 2025

But government interventions to improve prior authorization will be used “if we’re forced to use them,” Oz said during the news conference. Insurers also pledged to use clear language when communicating with patients and promised that medical professionals would review coverage denials. Reform efforts aren’t new.

Insurance 52

Insurance Patient-Centered Government Patients 52

GeriPal

JULY 20, 2023

Before we do, I think, Joe, you have a song request for Alex. Joe: I do. I would like to hear Space Oddity and it’s because I can’t imagine being more lonely and isolated than being in a tin can orbiting around the earth by myself and just how comforting it is even to hear that scratchy little voice from ground control. Joe: Right.

Telemedicine 73

Telemedicine Telehealth Patient-Centered Board-Certified 73

Physicians News Digest

APRIL 3, 2025

At their first meeting with the leadership of AHRQ last month, officials from Trump’s Department of Government Efficiency said that they didn’t know what the agency did — and that its budget would be cut by 80% to 90%, according to two people with knowledge of the meeting who were granted anonymity because of fears of retribution.

Patient-Centered 52

Patient-Centered Hospital Diagnose Medical 52