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Regulatory Compliance US Department of Health and Human Services FDA Licensing COVID-19 Vaccine Compliance Fraud Public Health Governance Medicare More Related Topics >
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SQA Regulatory Surveillance Summary | Monthly Update 2022 – Spring

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). Each of the above annexes provides detailed lists of elements to be examined for specific subject areas.

FDA 75
FDA Compliance Informed Consent Hospitals 75
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The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

DECEMBER 29, 2023

This year’s Drug & Device Law Blog top ten decisions of the year reinforced preemption – the most powerful defense we can assert. Plaintiff knew about it, too, since he signed an informed consent document mentioning it. Plaintiff’s complaints about “consent” related to the vaccination. Preemption.

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