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Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring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

Physician's Weekly

JUNE 15, 2025

Data was collected from 22 centers across North and South America, Asia, and Europe, following STROBE reporting guidelines. The dataset, acquired between 2000 and 2018, comprised OCT and clinical metadata.

Individual 52

Individual Patient-Centered Management Clinic 52

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

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers. FDA’s position is, however, only one side of the story.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

Annals of Family Medicine

NOVEMBER 20, 2024

A US-based study conducted by the Kaiser Family Foundation found 69% of patients reported avoiding discussions about death, but 92% reported feeling somewhat comfortable talking to a heath care provider about EOL wishes. Setting or Dataset: Outpatient palliative care cancer clinic at a tertiary health care center in the U.S.

Patients 130

Patients Patient-Centered Provider Education 130

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 could be in housing, it could be a standalone senior center, home delivered meals, nutrition counseling and nutrition education done by registered dieticians.

Community 89

Community Nurse Practitioner Provider IT 89