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run-fda-accelerated-approval-pmr

station__microgram__run-fda-accelerated-approval-pmr external (needs EXECUTION_BACKEND_URL) microgram pv-core Constructa Configa

FDA accelerated approval postmarketing requirements: routes by approval pathway and evidence status per FDA Guidance 'Labeling for Accelerated Approval' (2019) and PMR/PMC Annual Status (2023)

Taxonomy

Linnaean classification joined from the algovigilance taxonomy index via the parent config's rank.

Rank	Value
domain	`Substrata`
kingdom	`Constructa`
phylum	`Configa`
class	`station-config`
order	`microgram`
family	`mcp-tool-config`

Characteristics:

substrate: config
domain: pv
lifecycle: continuous
authority: read
compounding: producer
io: agent-request → tool-response

Input schema

approval_pathway stringrequired — Input parameter: approval_pathway
surrogate_endpoint_validated booleanrequired — Input parameter: surrogate_endpoint_validated
confirmatory_trial_status stringrequired — Input parameter: confirmatory_trial_status

Example call

POST /api/mcp
Content-Type: application/json

{
  "jsonrpc": "2.0",
  "id": 1,
  "method": "tools/call",
  "params": {
    "name": "station__microgram__run-fda-accelerated-approval-pmr",
    "arguments": {
      "approval_pathway": "",
      "surrogate_endpoint_validated": false,
      "confirmatory_trial_status": ""
    }
  }
}

How to invoke from a client

From any MCP-aware client, add https://algovigilance.com/api/mcp as an MCP server, then call this tool by name. From a raw HTTP client, send the JSON-RPC body above to /api/mcp.

Agent-friendly formats

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