# Microgram: fda-rems-modification-trigger

`station__algovigilance__microgram-fda-rems-modification-trigger` · native (always callable) · domain `algovigilance` · pv-relevance `pv-core`

FDA REMS modification decision tree: determines when a REMS requires modification based on safety signal type and evidence strength per FDA Guidance 'REMS Modifications and Revisions' (2019)

## Agent metadata

- `idempotent`: true
- `read_only`: true
- `expected_latency_ms`: unknown (not yet contract-tested)
- `cost_tokens_estimate`: unknown

## Input schema

- `signal_type` *string* (required) — Type of safety signal: new_risk, increased_frequency, new_population, reduced_risk, ineffective_rems
- `evidence_strength` *string* (required) — Strength of evidence: confirmed, probable, possible
- `current_rems_elements` *string* — Current REMS elements: medication_guide, communication_plan, etass, all

## Example call

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

{
  "jsonrpc": "2.0",
  "id": 1,
  "method": "tools/call",
  "params": {
    "name": "station__algovigilance__microgram-fda-rems-modification-trigger",
    "arguments": {
      "signal_type": "",
      "evidence_strength": ""
    }
  }
}
```

## Related

- [/tools](/tools) — all 7718 tools
- [/tools/algovigilance__microgram-fda-rems-modification-trigger](/tools/algovigilance__microgram-fda-rems-modification-trigger) — HTML page
- [/tools/algovigilance__microgram-fda-rems-modification-trigger/json](/tools/algovigilance__microgram-fda-rems-modification-trigger/json) — JSON form (agent-friendly)
- [/api/mcp](/api/mcp) — endpoint
- [/AGENTS.md](/AGENTS.md) — agent guide