FDA Law Blog

NOVEMBER 1, 2023

FDA recognizes that the FD&C Act exempts licensed healthcare practitioners from certain device regulations if they manufacture devices solely for use in the course of their professional practice. The PR goes on to state that the FD&C Act definition of a device does not turn on where or by whom a test system is “manufactured.”

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

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

Physician's Weekly

JUNE 12, 2025

Centers for Disease Control and Prevention (CDC) database that includes vaccine safety information from millions of patients, according to multiple sources. The two had access to the CDC database in 2004 and 2006. The VSD includes data from a dozen large healthcare networks. Results of that work are expected this fall.

Vaccination 52

Vaccination Patient-Centered Government Diagnosis 52

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 Family Families 126

Common Sense Family Doctor

MARCH 23, 2025

This post first appeared on March 6, 2018, during the first Trump administration's failed attempt to eliminate the Agency for Healthcare Research and Quality (AHRQ). Nonetheless, its work has often been politically unpopular and unheralded outside of a small community of health services researchers and patient advocates.

Healthcare 52

Healthcare Patient-Centered Primary Care Illness 52