Compliance FDA Informed Consent Nursing Homes 
SQA
MAY 17, 2022
China Regulatory Roundup: Latest Guidelines for Medical Device and IVD Compliance, 17 March 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).
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.
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