Health Law Advisor

APRIL 26, 2023

FDA have called into question the U.S. Food and Drug Administration’s (“FDA’s”) scientific review process to approve new drug applications. The Texas District Court ruling had the effect of suspending the FDA’s approval of mifepristone. During the past several turbulent weeks for the U.S. While the U.S.

FDA 97

FDA Hospitals Governance Compliance 97

SQA

SEPTEMBER 2, 2022

The Regulations were first issued with immediate effect in 2002 and were later revised in 2016. Good Practice Guide: Membrane Based WFI Systems, May 2002. ISPE Good Practice Guide: Critical Utilities GMP Compliance. United States Food and Drug Administration (FDA) – Regulations and Guidances.

FDA 91

FDA COVID-19 Nursing Homes Compliance 91

SQA

JULY 8, 2022

V60 and V60 Plus devices are designed for in-hospital use. Philips has no permanent solution to correct this issue, so the MHRA is issuing this alert to help hospitals manage the risk. All V680 invasive ventilators used in critical care settings are also affected. This alert should be acted on immediately.

Pharmaceutical Industry 40

Pharmaceutical Industry FDA Hospitals World Health 40

Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

FDA 98

FDA Licensing Hospitals Medicaid 98

SQA

AUGUST 2, 2021

ISO 10651-4:2002, Lung ventilators – Part 4: Particular requirements for operator-powered resuscitators. The following two PIC/S guidance documents have been revised: PE 005-4: PIC/S Good Practice Guidelines for Blood Establishments and Hospital Blood Banks. United States FDA – Guidances for Devices. b) and 320.31(d)(3)).

FDA 83

FDA COVID-19 Pharmaceutical Industry Hospitals 83

SQA

FEBRUARY 26, 2024

The reported irregularities and the manufacturing conditions of the products, that is, compliance with Good Manufacturing Practices, were verified on the spot. The MHRA has received reports of a very small number of people who have been hospitalized after using potentially fake pens.

FDA 52

FDA Compliance COVID-19 Public Health 52