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

Bill of Health

AUGUST 29, 2022

5] Stephanie Anne Deutsch & Kristine Fortin, Physical Health Problems and Barriers to Optimal Health Care Among Children in Foster Care , 45 Current Problems in Pediatric and Adolescent Health Care 286, 286 (2015); Council on Foster Care et al., 3] Bell, supra note 99 at 26. [4]

COVID-19 Vaccine 130

COVID-19 Vaccine COVID-19 Informed Consent Governance 130

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