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

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 125

Patient-Centered IT Family Families 125