Bill of Health

SEPTEMBER 23, 2022

Expanded Access is not intended to produce generalizable knowledge; however, it involves reporting of serious adverse events (SAEs) to the entity developing the product (the “sponsor”) and the regulatory agency (the U.S. patients each year. Who qualifies for EA, and how does it work? Full committee review is appropriate.

FDA 237

FDA Informed Consent Public Health 237

SQA

FEBRUARY 15, 2023

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. A concerted and collaborative effort is essential to address this threat to global health, economies, and security effectively.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

Hall Render

FEBRUARY 10, 2023

over Claims Practices Where things stand in Central California 1 month after a community hospital’s closure California hospital names Kelly Linden CEO Upcoming California health bills to watch, including a conversation with Rep. million to UMass Memorial Health Care for COVID-19 costs Four Mass. What to know.

US Department of Health and Human Services 40

US Department of Health and Human Services COVID-19 Nursing Homes Nurses 40

Drug & Device Law

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

FDA 105

FDA US Department of Health and Human Services COVID-19 Informed Consent 105

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