FDA Law Blog

MARCH 7, 2024

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

Clinic 105

Clinic Provider IT Utilities 105

Today's Hospitalist

APRIL 24, 2025

One VA center reduced its admission delay by almost one-third with a series of three interventions. Those interventions included standardizing both bed assignments and nursing handoffs while having ED providers—not an inpatient team—enter skeletal orders when deciding to admit a patient.

Hospital 52

Hospital Patient-Centered Patients Education 52

FDA Law Blog

NOVEMBER 1, 2023

The PR first sets out to establish that it has authority to regulate in vitro diagnostic “test systems” as devices, and not just the system’s individual components, such as reagents, instruments, specimen collection devices, and software. FDA’s position is, however, only one side of the story.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

Permanente Medicine

JUNE 3, 2025

They candidly discuss the unique challenges and opportunities health care organizations face in meeting patient expectations. Today we are talking about the patient care experience specifically here at Kaiser Permanente, but also in general. I joined SCPMG straight from residency in 2006. AM: Thank you so much.

IT 52

IT Patient-Centered Patients Medical 52

GeriPal

MARCH 2, 2023

The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. 2006 Transcript Eric: Welcome to the GeriPal Podcast. Annals of IM. Tasce: Yes.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

GeriPal

JULY 6, 2023

Started as a direct case manager, worked in a variety of different places including the state legislature and I’ve been with the state office now since 2006. It was designed to really balance what Medicaid at the time was to provide nursing homes and Medicare is obviously health insurance. Eric: And Susan?

Community 89

Community Nurse Practitioner Provider IT 89

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.”

Patient-Centered 126

Patient-Centered IT Families Family 126