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Home/Regulations/FDA Drug Approval (NDA/ANDA) — Regulatory Reference
Regulatory Reference
Pharmacy Federal (US) high

FDA Drug Approval (NDA/ANDA) — Regulatory Reference

Electronic records integrity for clinical and submission data — 21 CFR Part 11 audit trail requirements map to AutoPIL audit chain.

Key Provisions
  • 21 CFR Part 314 — applications for FDA approval
  • 21 CFR Part 11 — electronic records and signatures (cross-cutting)
  • GxP environments for submission-supporting data
  • Data integrity expectations (ALCOA+)
How AutoPIL Enforces It
  • Audit chain implements Part 11 audit trail expectations for AI in submission-supporting workflows
  • Agent registry binds AI agent identity to each electronic record action
  • Source registry differentiates GxP from non-GxP data sources
Audit LogPolicy EngineSensitivity LabelsLineage
AutoPIL Policy IDs
PHM-FDA-NDA-001Submission Data Integrity for AI
PHM-FDA-GXP-001GxP Source Boundary
Official Sources
https://www.fda.gov/drugs/types-applications/new-drug-application-ndahttps://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11

This page is a working reference and not a substitute for qualified legal review. Verify against official sources before use in compliance artifacts.

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