FDA Law Blog

APRIL 30, 2023

110-316 (2008) and by Section 1135 of the FDA Safety and Innovation Act (“FDASIA”), Pub. Senate Committee on Health, Education, Labor and Pensions (“Senate HELP”) is scheduled to take up legislation that could significantly limit access to the courts and immunize critical FDA decisions from timely judicial review. That bill is S.

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FDA Law Blog

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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FDA Law Blog

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. leave you scratching your head (we’ll call it “Who’s Buried in Grant’s Tomb?”). 351, 355-56 (1985). l 56(c)(4) and 37 C.F.R.

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GeriPal

MARCH 24, 2023

For others, this piece, while painful to read, gave voice to what they have been feeling over the last decade – hospice has in some ways lost its way in a quest of promoting profit over care. If you are interested in signing the position statement “Core Roles and Responsibilities of Physicians in Hospice Care”, click here. Is it you, Ira?

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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. Lynn: Okay.

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GeriPal

MAY 8, 2025

We’ll discuss three recent clinical trials involving patients with serious illness, joined by our guests James Downar , Ali John Zarrabi , and Margaret Ross. We begin with a refresher on psilocybinwhat it is, how it might work, what conditions it may help treat (including demoralization), and how its typically administered. It’s there.

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GeriPal

APRIL 14, 2022

Adapting Palliative Care Skills to Provide Substance Use Disorder Treatment to Patients With Serious Illness . It’s been around for a long time but is acting like the hot new kid in town. Just look at this year’s AAHPM meeting, where it felt like every other session was talking about how hot buprenorphine is right now. So here we go.

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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. Do you need to be an addiction medicine trained physician to start such a clinic (no: Sach is not). See Sachs write up about setting up this clinic in JPSM. Who will prescribe the buprenorphine then? Alex 03:48 Yeah.

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FDA Law Blog

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.,

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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. If you read just one, read Palliative Medicine – Just Another Specialty ? by Kearney. I promise its short.

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GeriPal

JUNE 30, 2022

Eric: So we’re going to be talking about dementia and considerations around surgery for individuals with dementia. Before we go into this topic, who has a song request for Alex? It was Remember Me. Was that the title? Alex: I think it’s I Will Remember You. Joel: Yeah, right, I Will Remember You, right. Alex: … Sarah McLachlan.

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FDA Law Blog

AUGUST 21, 2023

Koblitz & Deborah L. Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. Agency officials estimated that it took at least 6 years to complete the required rulemaking process.” More than a few have taken far longer—literally decades.

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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. You got it.

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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.” Malaz: I love it.

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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. Before we do, I think, Joe, you have a song request for Alex. Joe: I do. And the other reason is that you remind me of David Bowie. Eric: Wait, which version? The Labyrinth version or? Eric: David Bowie was in Labyrinth.

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PEMBlog

MAY 9, 2024

2008 Jul 15;71(3):170-6. Epub 2008 Jun 4. Shinnar S, Hesdorffer DC, Nordli DR Jr, Pellock JM, O’Dell C, Lewis DV, Frank LM, Moshé SL, Epstein LG, Marmarou A, Bagiella E; FEBSTAT Study Team. Phenomenology of prolonged febrile seizures: results of the FEBSTAT study. doi: 10.1212/01.wnl.0000310774.01185.97. 0000310774.01185.97.

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