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SQA Regulatory Surveillance Summary | Monthly Update 2022 – Spring

SQA

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.

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Health Provider News – February 10, 2023

Hall Render

deal to buy national physician practice Support grows for association health plans as small employer insurance costs soar Connecticut doctors call on legislature to tackle prior authorization during this year’s session CT hospitals support student-loan forgiveness, debt-free college programs to boost healthcare workforce DC D.C.’s

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The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

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