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SQA Regulatory Surveillance Summary | Monthly Update 2023 – March And April

SQA

MAY 24, 2023

European Medicines Agency (EMA) Final GCP Guideline on Computerized Systems and Data Integrity, 11 April 2023 Following the draft guideline published in June 2021 the final EMA Guideline on computerized systems and data integrity in clinical trials has now been published. In addition, a new expression is defined: ALCOA+. audit trail).

FDA 40
FDA Licensing Governance Compliance 40
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A Health-Heavy State of the Union

Kaiser Health News

FEBRUARY 9, 2023

Meanwhile, abortion rights advocates and opponents are anxiously awaiting a federal court decision out of Texas that could result in a nationwide ban on mifepristone, one of two drugs used in medication abortion. A decision is expected soon in a Texas court case challenging the future use of mifepristone. 9, at 10 a.m. So here we go.

US Department of Health and Human Services 52
US Department of Health and Human Services Medicare Medicare FDA 52
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