SQA

MAY 17, 2022

For Investigator Sites, the subject areas are Organizational Aspects, Informed Consent of Trial Participants, Review of Trial Participant Data, and Management of Investigational Medicinal Product(s). United States Food and Drug Administration (FDA) – Regulations and Guidances.

FDA 75

FDA Compliance Informed Consent Hospitals 75

Hall Render

FEBRUARY 10, 2023

billion since pandemic U.S. leading cause of death is heart disease, Alabama’s matches that Alabama lawmakers put temporary hold on $1 billion contract for prison healthcare New rolling NICU a ‘game changer’ for critical babies in Alabama More than a dozen Alabama hospitals at immediate risk of closing; officials say hospitals suffer $1.5

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