FDA Law Blog

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The final rule emphasizes risk management activities and risk-based decision making. Notably, Part 820 will look different.

Manufacturing 59

Manufacturing Management Medical IT 59

FDA Law Blog

APRIL 11, 2022

Shapiro — One of the more complex areas of device regulation is the management of risks associated with malfunctions reported from the field. By Jeffrey K. A critical task in this situation is for a firm to estimate the risk posed by the issue as accurately as possible.

Medical 40

Medical Management Manufacturing Patients 40

GeriPal

MARCH 2, 2023

By 2015 that number increased to 4% of US adults. 2022 Perioperative Gabapentin Use in Older AdultsRevisiting Multimodal Pain Management JAMA IM. And for that reason, there was actually an enormous lawsuit, and the manufacturer was fined, now I think 20 years ago, in the millions and millions of dollars for off-label prescribing.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

GeriPal

DECEMBER 7, 2023

And we have gone from 250 members at the end of 2015 to about 26,000 right now across the United States and a number of chapters that have grown. And so if you’re talking about healthcare providers and healthcare systems, start with waste and do an education with people of how to manage the waste. And you start small.

Healthcare 129

Healthcare IT Education Community 129

FDA Law Blog

SEPTEMBER 14, 2021

The MFP would be established through negotiations between HHS and the manufacturer and would incorporate foreign pricing benchmarks, as further described below. In order to permit MFPs to be negotiated under Part D, the current prohibition on Medicare negotiating with manufacturers would be repealed.

Manufacturing 52

Manufacturing Insurance Government Patients 52