FDA

Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management

The document describes how multiple patient-specific product variants may be included in a single Biologics License Application (BLA) under section 351(a) of the Public Health Service Act.
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EMA & FDA Guidelines: Guiding Principles of Good AI Practice in Drug Development (2026)

This document outlines 10 guiding principles for the development and use of AI technologies across all phases of the drug product life cycle
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