SQA

JUNE 10, 2021

Commission in March 2015 after the publication, in December 2014, of the Q3D Guideline on Elemental Impurities (EI) by the International Council for Harmonization (ICH). Backgrounder – Government of Canada Investments in Biomanufacturing, Development of COVID-19 Vaccines and Therapeutics, and Research, 18 May 2021.

FDA 52

FDA COVID-19 COVID-19 Vaccine Compliance 52

SQA

MAY 24, 2023

The company did not have a written procedure in place for the provision of information related to serious risk of injury to health, contrary to what was committed to on it establishment license application. The name and address of manufacturers provided by the company on its establishment license application were not accurate.

FDA 40

FDA Licensing Governance Compliance 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

FEBRUARY 26, 2024

The glossary was originally published in 2014 and has been used to define excipient terms and acronyms commonly found in IPEC guides. This standard is a globally recognized standard that provides guidelines for the governance and management of AI technologies.

FDA 52

FDA Compliance COVID-19 Public Health 52

Drug & Device Law

FEBRUARY 29, 2024

Not to mention, it is a powerful defense for our clients in product liability matters because it can foreclose liability and plaintiffs’ use of tort lawsuits (invariably creatures of state law origin) to impose requirements on medical devices or pharmaceuticals that the federal FDA did not. What could be better than preemption? United Bhd.

COVID-19 59

COVID-19 Informed Consent FDA Governance 59

Drug & Device Law

MAY 26, 2023

We are not looking do either of those, but we will weigh in on what NPP means for non-product liability cases involving FDA-regulated medical products. Both talk a fair amount about “commerce” and the respective roles of the states and federal government. Are we down to talk about NPP and its impact on reproductive rights litigation?

FDA 59

FDA Licensing Doctors Governance 59

Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. Are manufacturers liable only for failing to employ an alternative design that the FDA has approved for distribution. . .

FDA 59

FDA Licensing Hospitals Governance 59