plugin.json

{
  "$schema": "https://agent-plugins.org/schemas/1.0.0/plugin.schema.json",
  "name": "arca-life-sciences",
  "version": "1.0.2",
  "description": "Search Arca's public life-sciences corpus: FDA drug and device records, clinical trials, PubMed literature, VAERS, CDC data, and EU/PMDA device vigilance.",
  "author": {
    "name": "Arca",
    "email": "contact@arca.inc",
    "url": "https://arca.inc"
  },
  "homepage": "https://arca.inc",
  "keywords": [
    "FDA",
    "FDA records",
    "FDA database",
    "openFDA",
    "Drugs@FDA",
    "FDA approvals",
    "drug approvals",
    "warning letters",
    "FDA warning letters",
    "complete response letters",
    "CRL",
    "Form 483",
    "FDA inspections",
    "import refusals",
    "enforcement reports",
    "drug labels",
    "package insert",
    "prescribing information",
    "boxed warning",
    "DailyMed",
    "NDC",
    "NDC directory",
    "drug shortages",
    "Orange Book",
    "Purple Book",
    "patents and exclusivity",
    "biosimilars",
    "generic drugs",
    "product-specific guidance",
    "adverse events",
    "FAERS",
    "VAERS",
    "MAUDE",
    "pharmacovigilance",
    "drug safety",
    "recalls",
    "drug recalls",
    "device recalls",
    "postmarket requirements",
    "510(k)",
    "PMA",
    "predicate devices",
    "medical devices",
    "GUDID",
    "UDI",
    "AI-enabled devices",
    "EU MDR",
    "IVDR",
    "clinical trials",
    "ClinicalTrials.gov",
    "PubMed",
    "Europe PMC",
    "literature search",
    "systematic reviews",
    "citation counts",
    "open access papers",
    "regulatory",
    "regulatory affairs",
    "regulatory intelligence",
    "life sciences",
    "pharma",
    "biotech",
    "medical affairs",
    "quality assurance",
    "drug development",
    "meta-analysis",
    "medication",
    "drug information",
    "public health",
    "biomedical literature",
    "scientific papers",
    "research papers",
    "clinical research",
    "510k",
    "510k database",
    "510k search",
    "NDC lookup",
    "postmarketing requirements",
    "premarket approval",
    "substantial equivalence",
    "post-market surveillance",
    "medicine",
    "medical research",
    "vaccine adverse events",
    "CDC data",
    "citations",
    "clinical evidence",
    "phase 3 trials",
    "drug interactions",
    "labeling"
  ],
  "extensions": {
    "com.openai": {
      "interface": {
        "displayName": "Arca FDA, Trials & PubMed",
        "shortDescription": "Public FDA and health records",
        "longDescription": "Arca FDA, Trials & PubMed searches a curated index of public regulatory, clinical, and scientific records and returns results with links to the original source.\n\nWhat you can search:\n- FDA drug records: labels, Drugs@FDA approvals and review documents, complete response letters, warning letters, Form 483s, inspections, import refusals, Orange Book, Purple Book, NDC, drug shortages, and postmarket requirements\n- FDA device records: 510(k), PMA, registrations, GUDID, and MAUDE adverse event reports\n- ClinicalTrials.gov studies\n- PubMed and Europe PMC literature, ranked with citation counts and open-access status\n- VAERS, CDC public-health data, EU expert panels, and BfArM/PMDA device vigilance\n\nWho it is for: regulatory affairs, quality, pharmacovigilance, clinical, and medical-affairs teams, and anyone researching drugs, devices, or the evidence behind them.\n\nLimitations: it only searches public records that Arca mirrors, so it has no access to your own documents, patient data, or non-public FDA correspondence. It is read-only and cannot file reports or submissions. Results are research material, not medical advice.",
        "developerName": "Arca",
        "category": "Scientific Research",
        "capabilities": [
          "Search FDA drug and device records",
          "Search ClinicalTrials.gov studies",
          "Search PubMed literature",
          "Read the full text of a source record"
        ],
        "websiteURL": "https://arca.inc",
        "supportURL": "https://arca.inc/security",
        "privacyPolicyURL": "https://arca.inc/legal/privacy-policy",
        "termsOfServiceURL": "https://arca.inc/legal/terms-of-service",
        "defaultPrompt": [
          "Which patents and exclusivities are listed in the Orange Book for Ozempic?",
          "Find Phase 3 trials of tirzepatide in heart failure.",
          "What does the Ozempic label's boxed warning say?"
        ],
        "brandColor": "#222222",
        "composerIcon": "./assets/logo.png",
        "logo": "./assets/logo.png"
      },
      "review": {
        "test_cases": {
          "positive": [
            {
              "description": "Look up Orange Book patents and exclusivities",
              "prompt": "Which patents and exclusivities are listed in the Orange Book for Ozempic?",
              "tools_triggered": "search_medical",
              "expected_behavior": "Returns the Orange Book listing for Ozempic (semaglutide, NDAs 209637 and 213051) with its patent numbers, patent expiration dates, and any exclusivity codes, with a link to the FDA Orange Book."
            },
            {
              "description": "Read a drug label's boxed warning",
              "prompt": "What does the boxed warning on the Ozempic label say?",
              "tools_triggered": "search_medical, fetch_source_record",
              "expected_behavior": "Finds the Ozempic (semaglutide) label, reads the full record, and quotes the boxed warning on the risk of thyroid C-cell tumors, with a DailyMed link."
            },
            {
              "description": "Find clinical trials for a drug and indication",
              "prompt": "Find Phase 3 trials of tirzepatide in heart failure.",
              "tools_triggered": "search_medical",
              "expected_behavior": "Returns ClinicalTrials.gov studies of tirzepatide in heart failure, including the SUMMIT trial (NCT04847557), with links to clinicaltrials.gov."
            },
            {
              "description": "Find systematic reviews in the literature",
              "prompt": "Find meta-analyses on tirzepatide and pancreatitis or gallbladder risk.",
              "tools_triggered": "search_papers",
              "expected_behavior": "Returns PubMed systematic reviews or meta-analyses on tirzepatide safety, including pancreatitis and gallbladder or biliary disease, with year, journal, PMID, and citation metadata."
            },
            {
              "description": "Search device adverse event reports",
              "prompt": "Show me MAUDE adverse event reports for insulin pump malfunctions.",
              "tools_triggered": "search_medical",
              "expected_behavior": "Returns MAUDE device adverse event reports describing insulin pump malfunctions (for example MiniMed and Paradigm pumps), each with its report number and a link to the openFDA record."
            }
          ],
          "negative": [
            {
              "description": "Request unrelated to life sciences",
              "prompt": "Write a short poem about autumn in New York.",
              "expected_behavior": "Does not call any Arca tool, because the request has nothing to do with regulatory, clinical, or scientific records."
            },
            {
              "description": "Request for private data the plugin cannot access",
              "prompt": "Look up my prescription history and tell me which of my medications interact.",
              "expected_behavior": "Does not search for personal records. Explains that the plugin only covers public regulatory and scientific data and has no access to personal health information."
            },
            {
              "description": "Request to take an action the plugin cannot perform",
              "prompt": "File an adverse event report with the FDA for the reaction I had to my vaccine.",
              "expected_behavior": "Does not claim to file anything, because the plugin is read-only. Points the user to FDA MedWatch or VAERS to submit the report themselves."
            }
          ]
        },
        "demo_recording_url": "https://drive.google.com/file/d/1b6jJwNbUIwIhO6DAYELpO4eLJiOwjwpo/view?usp=sharing",
        "commerce": false,
        "commerce_description": "This plugin does not sell products or process payments."
      },
      "publication": {
        "release_notes": "Metadata update. The listing is renamed \"Arca FDA, Trials & PubMed\" (was \"Arca Life Sciences\") with a new subtitle, and gains discovery keywords for the record types the plugin already searches: warning letters, Orange Book, Purple Book, 510(k), MAUDE, ClinicalTrials.gov and others. The research-chat link now says it opens a longer multi-step search. No change to tools, data sources or privacy behavior; the v1.0.1 privacy notes (policy Section 5, case 16598479) still apply."
      },
      "apps": "./.app.json"
    }
  }
}