SQA

DECEMBER 16, 2022

This proposal builds upon the existing legal framework, which came into force in 2002 for blood and 2004 for tissues and cells. United States Food and Drug Administration (FDA) – Regulations and guidance. The FDA is issuing this guidance to provide clarity and predictability for software manufacturers on this topic.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

OCTOBER 18, 2023

The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products. At the same time, the EU has recognized the US FDA as an equivalent authority to carry out these inspections.

FDA 40

FDA Compliance Licensing World Health 40

Hall Render

FEBRUARY 2, 2024

Inman College of Nursing FDA clears Collierville startup CircumFix’s medical device for surgery, marketing FTC opposes Novant Health’s $320M hospital deal with Community Health Systems HCA CFO to retire HCA nets $5.2B for Dental Health OakLeaf Medical Network reaches out to HSHS WYOMING Gov.

Nursing Homes 40

Nursing Homes US Department of Health and Human Services Nurses Hospitals 40

Drug & Device Law

FEBRUARY 2, 2023

2004); and Hackett v. Texas, unlike most states, enforces a strong statutory presumption that prescription medical product warnings complying with FDA requirements imposed by “pre-market approval or licensing of the product” are adequate as a matter of law. March 4, 2005), rev’d on other grounds , 462 F.3d 3d 364 (5th Cir.

FDA 59

FDA Licensing Fraud 59