SQA

SEPTEMBER 2, 2022

On 09 May 2022, NMPA released the draft of the revised Regulations for Implementation of the Drug Administration Law (hereafter referred to as the Regulations ) for public comments. The Regulations were first issued with immediate effect in 2002 and were later revised in 2016.

FDA 91

FDA COVID-19 Nursing Homes Compliance 91

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. b) and 320.31(d)(3)). The 2015 draft guidance has been withdrawn.

FDA 83

FDA COVID-19 Pharmaceutical Industry Hospitals 83

SQA

FEBRUARY 26, 2024

This edition is aligned with the latest regulatory guidelines, including EU Annex 1 (revised 2022), EU Annex 15, the FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practices, and the FDA Draft Guidance for Industry: Current Good Manufacturing Practice for Medical Gases.

FDA 52

FDA Compliance COVID-19 Public Health 52