FDA Law

NOVEMBER 1, 2023

However, FDA states that this exemption does not apply to corporate or hospital laboratories that employ licensed practitioners, and the agency says FD&C Act otherwise contains no exception or limitation for devices manufactured by laboratories. Premarket Approval or De Novo pathways).

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Manufacturing Hospital Healthcare Medical 81

GeriPal

DECEMBER 2, 2022

When was that, 2010? Eric: 2010. Summary Transcript Summary. What would it take to transform dementia care? Alex: We have a full house today. We’re delighted to welcome Judy Long, who’s a palliative care chaplain at UCSF and a caregiver. Judy, welcome to the GeriPal podcast. Judy: Thank you. It’s great to be here.

Community 101

Community IT Individual Patient-Centered 101

FDA Law

AUGUST 18, 2024

Since 2010, FDA has posted classification orders and decision summaries for devices classified through the De Novo classification process. There was no time limit for De Novos, which meant some requests languished for prolonged periods. For the first fifteen years after the De Novo program was established, it was basically a failure.

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Specialization Hospital Physicals Provider 69

FDA Law

MAY 30, 2024

The 340B statute requires drug manufacturers to sell certain drugs at discounted ceiling prices to covered entities, which are defined by statute to include certain types of safety net hospitals, health centers, and clinics receiving federal grants.

Manufacturing 59

Manufacturing Patient-Centered Government Hospital 59

FDA Law

SEPTEMBER 29, 2021

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.

Manufacturing 52

Manufacturing Government Referral Provider 52

FDA Law

FEBRUARY 27, 2024

2010) , however, the U.S. leave you scratching your head (we’ll call it “Who’s Buried in Grant’s Tomb?”). Part 1: Multiple PTEs Under the PTE statute at 35 U.S.C. § Absent a convincing showing, the Office after considering all of Applicant’s argument plans to issue only one PTE directed to ZYDELIG® (idelalisib). l 56(c)(4) and 37 C.F.R.

Patients 59

Patients IT Provider Individual 59

The Health Policy Exchange

JANUARY 3, 2013

health care legislation until the 2010 Affordable Care Act. In fact, the reason that most provisions of the ACA, passed in 2010, don't take effect until 2014 was to allow the Congressional Budget Office - which didn't exist in 1965 - to artificially score it as deficit-reducing over a 10-year time period.)

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Insurance Family Medicine DO Finance 130

StorytellERdoc

JULY 17, 2020

His transport from his house to our department had been less than ten minutes and the pre-hospital team had done an excellent job of intubating this patient and establishing an IV to begin resuscitation efforts. Lying on the hospital cot. His wife was with him. Our reality was that time was not our friend. She understood my words. "I

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ER Families Family Patients 100

GeriPal

MAY 18, 2023

And then in 2010, the AGS took over because it was sort of wafting out there and people were wondering, when are you going to update it? And we were trying to get funding from different places and then AGS kind of stepped in and so they’ve been the stewards of it since 2010. Alex: We’re having Beers. Todd: Thank you.

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Medical IT Patients Clinic 97

GeriPal

JULY 28, 2022

Alex: And we are also delighted to welcome Areej El-Jawahri, who is an oncologist at Massachusetts General Hospital as well, who specializes in blood cancers. Jennifer’s study is most widely known for the “kicker” – not only did it improve quality of life, palliative care was associated with a couple months longer survival. .

Illness 110

Illness Hospital Patient-Centered Patients 110

Georgetown Pediatrics & Family Medicine

FEBRUARY 7, 2022

Daniel Hale Williams practiced medicine during an era when racism and discrimination prohibited African Americans from being admitted to hospitals and denied black doctors employment on hospital staff. In 1891, Williams opened Provident Hospital, the first medical facility to have an interracial staff.

Mental Health 40

Mental Health Patient-Centered Hospital Education 40

GeriPal

APRIL 13, 2023

Summary Transcript Summary Social connections impact our health in profound ways, whether it is the support we receive from family and friends in navigating serious illness, the joy from shared social activities, or connecting with our community. Welcome back, Ashwin. Ashwin Kotwal: Excited to be back. Eric: Now, it’s interesting. Alex: Great.

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IT Community Patient-Centered Medical 99

GeriPal

AUGUST 25, 2022

That trajectory was in increase from 2000 to say, 2010. For-profit hospices having much higher rates of their patients visiting the emergency department and being hospitalized, in addition to disenrollment. We’re going to be talking about each one of these papers. But before we do, I think somebody has a song request. Here we go.

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Families Family IT Patients 106

GeriPal

JUNE 22, 2023

Today’s podcast is part one of a two-part podcast where we spend a day at CMF, a medium security prison located about halfway between San Francisco and Sacramento, and the hospice unit housed inside its walls. Afterwards, we chat with the prison’s chaplain, Keith Knauf. And it’s an incredibly compelling place to work. Eric: Yeah. Alex: Yeah.

Families 132

Families Family IT Community 132

GeriPal

JUNE 5, 2025

Cari 01:42 I would like to request Hallelujah, one of my favorite songs. And I love hearing you sing, and so it’s an excuse to have you sing a beautiful song. And it’s, I think, a very uplifting song. And I’m so pleased with Connie and that she’s doing so well, and so it’s a celebration of her, too. No problem.

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Nurse Practitioner Referral Consulting Board-Certified 78

GeriPal

MARCH 10, 2022

On today’s podcast we dive into drivers of invasive procedures and hospitalizations in advanced dementia by talking to some pretty brilliant nursing and nurse practitioner researchers focused on dementia, geriatrics, and palliative care in nursing homes: Ruth Palan Lopez, Caroline Stephens, Joan Carpenter, and Lauren Hunt. Rehabbed to Death.

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Nurse Practitioner Hospital Families Family 60

PEMBlog

JUNE 5, 2024

Epub 2010 Oct 29. Cervical Spine Injuries are fortunately rare in children. this episode is all about learning when to suspect them, how to immobilize the C-spine properly, and which imaging test to choose. Factors associated with cervical spine injury in children after blunt trauma. Ann Emerg Med. 2011 Aug;58(2):145-55. 2010.08.038.

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Patient-Centered Patients IT Hospital 52

GeriPal

SEPTEMBER 19, 2024

Alex 00:34 We are delighted to welcome back Jennifer Tem e l, who is a thoracic oncologist at Massachusetts General Hospital in Boston. Summary Transcript CME Summary If palliative care was a drug, one question we would want to know before prescribing it is what dose we should give. Give too little – it may not work. At some point.

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Patient-Centered IT Patients Hospital 119

Common Sense Family Doctor

APRIL 25, 2025

Before becoming a core faculty member at the Lancaster General Hospital Family Medicine Residency Program , I spent more than 15 years teaching in Georgetown's family medicine department. The number of visits to primary care physicians fell by 43% from 2010 to 2021 despite 7.4% growth in the U.S. And if you build it, will they come?

Family Medicine 52

Family Medicine DO Families Family 52

Common Sense Family Doctor

MARCH 23, 2025

Despite this deliberately circumscribed mandate (I lost count of the number of times during my tenure as an AHRQ medical officer from 2006-2010 that I was told, "We don't make guidelines. Now the Department of Government Efficiency is trying again, threatening 90% staff reductions that would decimate the agency.

Healthcare 52

Healthcare Patient-Centered Primary Care Illness 52

PEMBlog

JANUARY 17, 2024

This episode will help you recognize cellulitis and even differentiate it from erysipelas which is totally a different thing. You’ll also learn about treatment, whether or not a blood culture is necessary, and a whole lot more. Randomized controlled trial of cephalexin versus clindamycin for uncomplicated pediatric skin infections. Pediatrics.

IT 59

IT Patients Diagnosis Clinic 59

Physician's Weekly

JUNE 17, 2025

Prior authorization varies by plan but often requires patients or their providers to get permission (also called precertification, preauthorization, or preapproval) before filling prescriptions, scheduling imaging, surgery, or an inpatient hospital stay, among other expenses. “They’re, like, not accountable to anyone.”

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Insurance Patients Behavioral Health Services Diagnose 52