FDA Law

MAY 3, 2021

The implementing regulations provide an alternative option for delayed submission of results information if the responsible party submits a certification that a premarket submission “has been filed or will be filed within 1 year” of the reporting deadline. The ClinicalTrials.gov database was launched more than 10 years ago in 2008.

Clinic 52

Clinic Patient-Centered IT Provider 52

FDA Law

MAY 3, 2021

The implementing regulations provide an alternative option for delayed submission of results information if the responsible party submits a certification that a premarket submission “has been filed or will be filed within 1 year” of the reporting deadline. The ClinicalTrials.gov database was launched more than 10 years ago in 2008.

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Clinic Patient-Centered IT Provider 40

FDA Law

FEBRUARY 27, 2024

For years after the enactment of the Hatch-Waxman Amendments the PTO interpreted the PTE statute to permit multiple PTEs, provided there are separate, but not necessarily different, regulatory review periods. See Lourie, Patent Term Restoration: History, Summary, and Appraisal, 40 Food, Drug, and Cosm. 351, 355-56 (1985).

Patients 59

Patients IT Provider Individual 59

GeriPal

JANUARY 12, 2023

Yes, you need some protected time for leaders to provide training and structure and oversight and ongoing quality assurance, but the heaviest sort of cost lift sometimes is redesigning the physical space. So the system drives the providers to deliver age friendly care. And so there’s not a lot of added cost. Eric: Okay.

Hospital 101

Hospital Patient-Centered IT Nurse Practitioner 101

FDA Law

APRIL 30, 2023

110-316 (2008) and by Section 1135 of the FDA Safety and Innovation Act (“FDASIA”), Pub. 1067 might allow these issues to be litigated months down the road therefore provides no solace: That’s far too late for patients, sponsors, and the broader public. 110-85 (2007), as amended by Section 301 of Pub. 112-144 (2012). The fact that S.

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IT Education Patients Provider 59

FDA Law

NOVEMBER 21, 2024

temporary exceptions from some of the requirements of the Ryan Haight Act of 2008) are extended for an additional year, until December 31, 2025. Any refill, however, would require an in-person exam either by a “referring” provider or dispensing provider. The federal telemedicine flexibilities (i.e.,

Telemedicine 52

Telemedicine Provider Medical Patients 52

GeriPal

MARCH 24, 2023

She happened to focus on some specific for-profit hospice providers. They were all actually publicly traded or private equity owned for-profit hospice providers. And I didn’t read it as damning of all for-profit providers, but I think it needed to happen. It feels somewhat random in some ways. Eric: Lack of a caregiver.

IT 115

IT Provider Patients Families 115

GeriPal

FEBRUARY 29, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

IT 127

IT Patient-Centered Illness Education 127

GeriPal

MAY 8, 2025

So these were people who are felt to have like, all you had to do is basically have more than a month to live just so we could get through the protocol in order to be included in the study and followed by a palliative care provider. Some of them also had psychiatric or psychosocial oncology providers as well.

Illness 109

Illness IT Patient-Centered Patients 109

GeriPal

APRIL 14, 2022

Adapting Palliative Care Skills to Provide Substance Use Disorder Treatment to Patients With Serious Illness . And that’s a lot easier if all providers were X waivered too. So this is 2008 when they were running this study, I’m like why did the heck did they choose buprenorphine? Nobody uses buprenorphine.

Illness 103

Illness Patient-Centered IT Patients 103

GeriPal

FEBRUARY 27, 2025

But, you know, I’ve talked to a lot of palliative care providers, a lot of people caring for people with serious illness. I think in the era when I trained in the 2008 timeframe, you know, it was very much just like somebody has pain, they need opioids, they have pain, they have more pain, they need lots more opioids.

Patients 74

Patients Clinic Patient-Centered Illness 74

GeriPal

JUNE 30, 2022

That provision was taken out of Obamacare back in 2007, 2008. And I try to provide as much objective data as I can on mortality risk and complication risk, but I also try to paint a clear picture of what life may look like afterwards, what the best case scenario is, the worst case scenario, and the most likely case scenario.

Patient-Centered 101

Patient-Centered Complication Patients IT 101

FDA Law

AUGUST 21, 2023

Recall that the funds provided under the Prescription Drug User Fee Acts (PDUFA) are not available to support the agency’s efforts related to monograph drugs.) The GAO Report further explained that the agency did not have the resources to regulate the estimated 100,000 OTC drugs marketed through the monograph process.

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Manufacturing Consulting Healthcare Professional Vaccination 40

GeriPal

MARCH 13, 2025

Eric 01:44 And we’re going to be talking about the roots of palliative care, and I think importantly, not just looking back, but what does that mean for our future as hospice and palliative care providers. But before we do, I think, Justin, you have a song request for Alex. Justin 01:59 Absolutely. It’s I Got a Name by Jim Croce.

IT 105

IT Patient-Centered Families Family 105

GeriPal

JULY 25, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Families 108

Families Family Patient-Centered Patients 108

GeriPal

DECEMBER 21, 2023

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.” Eric: Okay.

Patient-Centered 126

Patient-Centered IT Families Family 126

GeriPal

JULY 20, 2023

And the Ryan Haight Act I think was passed in 2008, which was in response to a young person who died of an opioid overdose. What was life for you as a provider pre-pandemic? And so we’re able to provide access to those patients that may be home-bound or home limited or have a lot of struggles to get in.

Telemedicine 73

Telemedicine Telehealth Patient-Centered Board-Certified 73

PEMBlog

MAY 9, 2024

2008 Jul 15;71(3):170-6. Epub 2008 Jun 4. In a wonderfully named study called Febstat, which was initially published back in 2008 as a multi center perspective cohort of 119 children one month of five years with febrile status, they noted that the median duration of seizures was 68 minutes. doi: 10.1212/01.wnl.0000310774.01185.97.

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Illness Vaccination Families Family 59