The FDA Law Blog

FEBRUARY 13, 2025

The update procedures should include how the AI-DSF modifications will be implemented and communicated to end users. Impact Assessment The Impact Assessment documents the benefits and risks of implementing the AI-DSF and the mitigations for the identified risks. In such cases, performance testing may be conducted again.

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ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

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ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g., Accessed 7 September 2021.

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Documentation FDA Communication Packaging 52