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Article FDA Thank You FDA updates set the stage for broader use of harmonized standards for safety reporting

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APRIL 8, 2024

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ).

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Article FDA Thank You FDA updates set the stage for broader use of harmonized standards for safety reporting

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