FDA Law

MAY 3, 2021

for failure to submit the required information following completion of a clinical trial evaluating the safety and effectiveness of the drug dalantercept in combination with axitinib in patients with advanced renal cell carcinoma (see FDA press release announcing the Notice of Noncompliance here ). 42 C.F.R. §§ 11.10, 11.44(a).

Clinic 52

Clinic Patient-Centered IT Provider 52

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

FDA Law

MAY 3, 2021

for failure to submit the required information following completion of a clinical trial evaluating the safety and effectiveness of the drug dalantercept in combination with axitinib in patients with advanced renal cell carcinoma (see FDA press release announcing the Notice of Noncompliance here ). 42 C.F.R. §§ 11.10, 11.44(a).

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Clinic Patient-Centered IT Provider 40

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).

IT 59

IT Education Patients Provider 59

GeriPal

FEBRUARY 27, 2025

We address: Why is caring for patients with this overlap so hard? Sach Kale set up an outpatient clinic focused on substance use disorder for patients with cancer. Who follows the patient once the cancer goes into remission? Why am I having difficulty with this patient? Why am I feeling frustrated with this patient?

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Patients Clinic Patient-Centered Illness 73

GeriPal

APRIL 14, 2022

Adapting Palliative Care Skills to Provide Substance Use Disorder Treatment to Patients With Serious Illness . And I remember being there and there was a patient who had seen inpatient and then subsequently outpatient who was so thankful in the weirdest in just this irrational way for having been diagnosed with liver cancer.

Illness 102

Illness Patient-Centered IT Patients 102

GeriPal

MARCH 24, 2023

I’m very proud of the work that we do every day and we take care of patients and families no matter where they live or who they are to help them meet their end of life goals. She happened to focus on some specific for-profit hospice providers. So hospices have been around for decades, generally provide higher level care.

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IT Provider Patients Families 114

GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. Then fast forward a year.

Illness 107

Illness IT Patient-Centered Patients 107

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. use of buprenorphine) for opioid use disorder, and for Schedule III-V non-narcotic controlled substances unless the patient receives an in-person examination.

Telemedicine 52

Telemedicine Provider Medical Patients 52

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 126

IT Patient-Centered Illness Education 126

GeriPal

JUNE 30, 2022

You have a patient with dementia severe enough that she cannot recognize relatives. A huge part of this decision rests on (1) her previously stated wishes, values, and goals (prior to the onset of dementia); and (2) the outcomes of surgery for patients with dementia. Summary Transcript Summary. She falls and breaks her hip.

Patient-Centered 101

Patient-Centered Complication Patients IT 101

GeriPal

MARCH 13, 2025

Yes, it means to cloak, but theres more Whole-person-care Total pain Healing as a process distinct from the deterioration of the body Sympomatologists The patient and family as the unit of care Our guests referenced many articles on this podcast, linked above and below. We each had an average between 23 and 25 patients each.

IT 104

IT Patient-Centered Families Family 104

FDA Law

AUGUST 21, 2023

After all, the labeling is intended to do exactly that: it informs patients and prescribers of the risks to ensure the product is used effectively and in a manner that mitigates risks, according to FDA’s understanding of the relevant science. FDA, for years, has been concerned with overwarning.

Manufacturing 40

Manufacturing Consulting Healthcare Professional Vaccination 40

GeriPal

JULY 25, 2024

The PPS is one of the most widely used prognostic tools for seriously ill patients, but the prognostic estimates given by the PPS are based on data that is well over a decade old. It is appropriate for all patient populations, and it is developed specifically for the palliative care and hospice populations. Why do this?

Families 106

Families Family Patient-Centered Patients 106

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.” Everything.

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Patient-Centered IT Families Family 125

GeriPal

JULY 20, 2023

Clinicians could care for patients across state lines, could prescribe opioids without in person visits, could bill at higher rates for telemedicine than previous to the pandemic. Many patients benefited, not only those isolating due to covid, but also patients in rural areas, patients who are homebound, and many others.

Telemedicine 73

Telemedicine Telehealth Patient-Centered Board-Certified 73

PEMBlog

MAY 9, 2024

2008 Jul 15;71(3):170-6. Epub 2008 Jun 4. Both the motor movements and characteristics of the seizure, as well as the duration, are really hard to assess in a patient’s home. You should develop a specific plan for each patient with each patient. doi: 10.1212/01.wnl.0000310774.01185.97. 0000310774.01185.97.

Illness 59

Illness Vaccination Families Family 59