Health Care Compliance Brief

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sponsors olympus

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

SQA

MAY 24, 2023

Medicine sponsors have 3 years to update labels to show only the new name for these ingredients. United States Food and Drug Administration (FDA) – Warning Letters Olympus Medical Systems Corp., Warning Letter, 15 March 2023 The FDA inspected the Olympus Medical Systems Corp.

FDA

FDA Licensing Governance Compliance

SQA Regulatory Surveillance Summary | Monthly Update 2024

SQA

FEBRUARY 26, 2024

The sponsor did not implement systems and procedures to ensure: The drug was properly handled. The sponsor did not record, handle, and store all information for the delegation of tasks in the clinical trial to allow for complete and accurate reporting, interpretation, and verification. Adequate monitoring of the clinical trial.

FDA

FDA Compliance COVID-19 Public Health

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

SQA Regulatory Surveillance Summary | Monthly Update 2024

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