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US Food and Drug Administration

fda.gov · CLASP-conformant Content Owner (fictional)

Standards

• Aseptic-Processing-CGMP — FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice (1 edition)
• Data-Integrity-CGMP — FDA Guidance for Industry: Data Integrity and Compliance With Drug CGMP — Questions and Answers (1 edition)
• Part-11-Scope-and-Application — FDA Guidance for Industry: Part 11, Electronic Records; Electronic Signatures — Scope and Application (1 edition)

Endpoints

• GET /fda/.well-known/clasp-catalog (CatalogIndex)
• POST /fda/api/oauth/token — mock OAuth2
• POST /fda/api/handshake — CoMP handshake
• POST /fda/api/mcp — MCP (Bearer required)