Health Populi

JULY 28, 2020

Twelve years ago, when I began to attend CES, digital health was a nascent category featured with products featured in a couple of aisles in exhibit booths then dominated by Fitbit, Nike and UnderArmour. The company’s Core ScanWatch was a CES 2020 Honoree in the category of Fitness/Sports and Wearable Technologies.

Public Health 116

Public Health COVID-19 Telemedicine FDA 116

Health Law Advisor

FEBRUARY 1, 2022

The United States Food and Drug Administration (FDA) for many years has been trying to increase the participation of minorities in clinical trials to help ensure that regulated products are tested and labeled in an appropriate cross-section of Americans. National Library of Medicine, with support from FDA.

FDA 52

FDA Compliance 52

Drug & Device Law

JANUARY 30, 2023

440 (2008) Buckman was not cited at all in the Merck Sharp & Dohme Corp. 470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Kent , 552 U.S. Lohr , 518 U.S.

FDA 72

FDA Fraud Governance Medicare 72

Drug & Device Law

SEPTEMBER 18, 2023

He came across several preemption decisions involving defendants who employed the FDA’s “alternative summary reporting” (“ASR”) system that the agency operated for about 20 years, “from 1997 through June 2019.” without adversely affecting FDA’s ability to monitor and react to such events.

FDA 59

FDA Fraud Governance Compliance 59