FDA Product Intelligence

Get a comprehensive FDA regulatory intelligence report for any drug, device, or food product — combining approvals, adverse events, and recalls from 9 openFDA endpoints in a single run. Search by product name, company name, or both, and receive a unified risk-assessed profile with cross-domain timeline, key findings, and aggregate safety statistics.

Why Use This Actor?

• One query, full picture — queries 9 separate FDA endpoints in parallel and returns a single intelligence report instead of requiring 9 separate API integrations
• Risk assessment — automatically computes a risk level (CRITICAL / HIGH / MODERATE / LOW / MINIMAL) based on Class I recalls, death reports, adverse event seriousness rates, and ongoing recalls
• Key findings — generates human-readable insights like "34,791 death-associated drug adverse event reports" and "2 Class I recall(s) — most serious category"
• Cross-domain timeline — builds a chronological timeline of approvals, clearances, and recalls across drugs, devices, and food
• Smart aggregation — uses openFDA count endpoints for adverse event statistics (top reactions, outcomes, seriousness) instead of fetching millions of individual records
• No API key needed — uses the free public openFDA API

Key Features

• Searches across 3 FDA domains: drugs, medical devices, and food/supplements
• Queries 9 openFDA endpoints in parallel: drug approvals, drug adverse events, drug recalls, device 510(k) clearances, device PMA approvals, device adverse events (MAUDE), device recalls, food adverse events (CAERS), and food recalls
• Computes risk level from Class I recall counts, death-associated reports, seriousness ratios, and ongoing recalls
• Generates key findings — a bullet list of the most important regulatory signals
• Builds a cross-domain timeline — approval dates, clearance dates, and recall dates sorted chronologically
• Returns aggregate adverse event statistics — total reports, serious count, death count, and top 15 reaction/outcome terms
• Configurable search scope — search all domains or narrow to drugs, devices, or food only
• Parallel execution — all endpoint queries run concurrently for fast results (typically 2-5 seconds)
• Automatic retry with backoff on rate limits and transient errors

How to Use

1. Go to the actor's input page on Apify Console
2. Enter a Product Name (e.g. "metformin", "pacemaker") and/or Company Name (e.g. "Pfizer", "Medtronic")
3. Optionally select a Search Scope to narrow results to a specific domain
4. Optionally set a date range to filter results
5. Click Start and wait for the intelligence report
6. Download the report from the Dataset tab

Input Parameters

*At least one of productName or companyName is required.

Input Examples

Drug safety profile

{
    "productName": "metformin",
    "searchScope": "drugs"
}

Company-wide regulatory intelligence

{
    "companyName": "Medtronic",
    "searchScope": "all"
}

NDMA contamination investigation

{
    "productName": "valsartan",
    "searchScope": "drugs",
    "dateFrom": "2018-01-01",
    "dateTo": "2023-12-31"
}

Medical device due diligence

{
    "productName": "pacemaker",
    "companyName": "Medtronic",
    "searchScope": "devices",
    "maxResultsPerCategory": 50
}

Input Tips

• Use brand names (Lipitor) or generic names (atorvastatin) for drug searches — both are searched
• Company names for drug approvals are automatically uppercased (FDA stores sponsor names in ALL CAPS)
• Set searchScope to a specific domain if you know the product type — this reduces API calls and speeds up the response
• The maxResultsPerCategory only limits detailed records (approvals, recalls). Adverse event aggregates (totals, top reactions) always include all matching records
• Date filters apply differently per endpoint — typically filtering on report date, approval date, or event date as appropriate

Output

The actor produces a single intelligence report record:

{
    "query": {
        "productName": "metformin",
        "companyName": "",
        "searchScope": "drugs",
        "searchedAt": "2026-02-25T10:30:00.000Z"
    },
    "summary": {
        "riskLevel": "CRITICAL",
        "totalFindings": 11,
        "domainsWithData": ["drugs"],
        "keyFindings": [
            "Earliest drug approval: NDA NDA021842 (2009-10-21)",
            "5 drug application(s) found",
            "428,781 total adverse event reports across all domains",
            "34,791 death-associated drug adverse event reports",
            "Top drug adverse reaction: NAUSEA (29,312 reports)",
            "5 recall(s) found",
            "⚠ 1 Class I recall(s) — most serious category",
            "1 ongoing/active recall(s)"
        ],
        "classIRecalls": 1,
        "deathReports": 34791,
        "totalAdverseEvents": 428781,
        "totalRecalls": 5,
        "totalApprovals": 5
    },
    "drugs": {
        "approvals": [
            {
                "applicationNumber": "NDA021842",
                "applicationType": "NDA",
                "sponsorName": "TAKEDA PHARMS USA",
                "brandNames": ["ACTOPLUS MET"],
                "genericNames": ["PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE"],
                "activeIngredients": ["PIOGLITAZONE HYDROCHLORIDE", "METFORMIN HYDROCHLORIDE"],
                "dosageForms": ["TABLET"],
                "routes": ["ORAL"],
                "productCount": 4,
                "submissionCount": 22,
                "originalApprovalDate": "2009-10-21"
            }
        ],
        "adverseEvents": {
            "totalReports": 428781,
            "seriousCount": 285471,
            "deathCount": 34791,
            "topReactions": [
                { "term": "NAUSEA", "count": 29312 },
                { "term": "BLOOD GLUCOSE INCREASED", "count": 27459 },
                { "term": "DIARRHOEA", "count": 27320 },
                { "term": "DRUG INEFFECTIVE", "count": 22196 },
                { "term": "LACTIC ACIDOSIS", "count": 18415 }
            ]
        },
        "recalls": [
            {
                "recallNumber": "D-0435-2021",
                "classification": "Class II",
                "status": "Terminated",
                "recallingFirm": "Cardinal Health Inc.",
                "productDescription": "xigduo XR (dapgliflozin/metformin HCl extended-release) tablets ...",
                "reasonForRecall": "CGMP Deviations: Intermittent exposure to temperature excursion",
                "recallInitiationDate": "2021-03-15",
                "distributionPattern": "FL, GA, SC",
                "brandNames": ["XIGDUO"]
            }
        ]
    },
    "devices": null,
    "food": null,
    "timeline": [
        {
            "date": "2025-11-10",
            "domain": "drug",
            "type": "approval",
            "description": "ANDA ANDA090564 approved — METFORMIN HYDROCHLORIDE"
        },
        {
            "date": "2025-02-25",
            "domain": "drug",
            "type": "recall",
            "description": "Class II drug recall by A-S Medication Solutions LLC — Presence of Foreign Tablet"
        }
    ]
}

Output Fields

Query Metadata

Summary

Drug Intelligence (drugs)

Device Intelligence (devices)

Food Intelligence (food)

Timeline

Risk Level Methodology

Use Cases

• Pharma due diligence — Before acquiring a drug portfolio, get the full regulatory profile: approvals, recall history, adverse event trends, and risk level in one report
• Medical device evaluation — Research a device's 510(k) clearances, PMA approvals, MAUDE reports, and recall history before procurement
• Drug safety research — Investigate a drug's adverse event profile including top reactions, death counts, and seriousness rates
• NDMA/contamination investigation — Track recalls and adverse events for drugs affected by impurity contaminations (valsartan, ranitidine, metformin)
• Competitor intelligence — Search by company name to see a competitor's full FDA regulatory footprint across all product domains
• Regulatory compliance monitoring — Schedule weekly runs to track evolving risk profiles for products in your portfolio
• Supply chain risk assessment — Evaluate manufacturer recall history and adverse event patterns before sourcing decisions
• Legal research — Build a complete regulatory timeline for litigation involving drug or device safety claims

API Examples

Python

from apify_client import ApifyClient

client = ApifyClient("YOUR_API_TOKEN")
run = client.actor("ryanclinton/fda-product-intelligence").call(run_input={
    "productName": "metformin",
    "searchScope": "drugs",
})

report = list(client.dataset(run["defaultDatasetId"]).iterate_items())[0]
print(f"Risk Level: {report['summary']['riskLevel']}")
print(f"Key Findings:")
for finding in report['summary']['keyFindings']:
    print(f"  - {finding}")

JavaScript

import { ApifyClient } from 'apify-client';

const client = new ApifyClient({ token: 'YOUR_API_TOKEN' });
const run = await client.actor('ryanclinton/fda-product-intelligence').call({
    productName: 'pacemaker',
    companyName: 'Medtronic',
    searchScope: 'devices',
});

const { items } = await client.dataset(run.defaultDatasetId).listItems();
const report = items[0];
console.log(`Risk: ${report.summary.riskLevel}`);
console.log(`Device AE: ${report.devices?.adverseEvents.totalReports.toLocaleString()}`);

cURL

curl "https://api.apify.com/v2/acts/ryanclinton~fda-product-intelligence/run-sync-get-dataset-items?token=YOUR_API_TOKEN" \
  -X POST \
  -H "Content-Type: application/json" \
  -d '{"productName": "valsartan", "searchScope": "drugs"}'

How It Works

                    ┌─────────────────────┐
                    │   Product / Company  │
                    │      Query Input     │
                    └──────────┬──────────┘
                               │
                    ┌──────────▼──────────┐
                    │    Scope Router     │
                    │  drugs/devices/food │
                    └──────────┬──────────┘
                               │
          ┌────────────────────┼────────────────────┐
          │                    │                     │
    ┌─────▼─────┐       ┌─────▼─────┐        ┌─────▼─────┐
    │   DRUGS   │       │  DEVICES  │        │   FOOD    │
    │           │       │           │        │           │
    │ drugsfda  │       │  510k     │        │ food/event│
    │ drug/event│       │  pma      │        │ food/enf  │
    │ drug/enf  │       │ device/evt│        │           │
    │           │       │ device/enf│        │           │
    │ 3 results │       │ 4 results │        │ 2 results │
    │ 2 counts  │       │ 2 counts  │        │ 2 counts  │
    └─────┬─────┘       └─────┬─────┘        └─────┬─────┘
          │                    │                     │
          └────────────────────┼────────────────────┘
                               │
                    ┌──────────▼──────────┐
                    │   Intelligence      │
                    │   Engine            │
                    │                     │
                    │ • Risk Assessment   │
                    │ • Key Findings      │
                    │ • Timeline Builder  │
                    │ • Domain Merging    │
                    └──────────┬──────────┘
                               │
                    ┌──────────▼──────────┐
                    │  Unified Report     │
                    │  to Apify Dataset   │
                    └─────────────────────┘

Endpoints Queried

Data Source

All data comes from the openFDA API (api.fda.gov), the U.S. Food and Drug Administration's public data platform. Data is updated regularly (typically weekly) and covers:

• Drug approvals: ~29K applications (NDA, ANDA, BLA)
• Drug adverse events: ~27M FAERS reports
• Drug recalls: ~17K enforcement reports
• Device clearances: ~230K 510(k) records
• Device approvals: ~56K PMA records
• Device adverse events: ~19M MAUDE reports
• Device recalls: ~38K enforcement reports
• Food adverse events: ~148K CAERS reports
• Food recalls: ~25K enforcement reports

Cost Estimate

Tips

• Start broad, then narrow: Run with searchScope: "all" first to see which domains have data, then follow up with domain-specific searches and higher maxResultsPerCategory for the relevant domain
• Schedule for monitoring: Set up a weekly schedule to track evolving risk profiles — new recalls, increasing adverse event counts, or new approvals
• Company vs. product: Company searches work best for devices (applicant field). Product name searches work best for drugs (brand_name, generic_name fields)
• Risk level context: A CRITICAL or HIGH risk level doesn't necessarily mean the product is unsafe — metformin has 34K death reports because it's prescribed to millions of diabetic patients. Context matters

Limitations

• openFDA caps results at 1,000 per endpoint — for products with more records, the actor returns a representative sample plus aggregate statistics
• Adverse event reports are not proof of causation — a drug listed in an adverse event report may not have caused the reaction
• Not all records have openFDA enrichment — some enforcement reports lack brand_name/generic_name cross-references
• Food/event endpoint doesn't support company-name-only searches — productName is needed for food adverse event queries
• The serious count on drug/event uses the FDA's seriousness flag (1=serious, 2=not serious) which is reporter-dependent
• Date range filters apply to different date fields per endpoint (report_date, decision_date, receivedate, etc.)

Responsible Use

• All data comes from public FDA records — no proprietary or restricted data is accessed
• Adverse event reports are not validated by FDA and should not be used for clinical decision-making
• This actor is designed for research and intelligence purposes — not as a substitute for professional regulatory advice
• Recall data may include terminated recalls that have been fully resolved
• Risk levels are computed algorithmically and should be interpreted with appropriate context

FAQ

Q: Do I need an API key? A: No. The openFDA API is free and public. No API key is required.

Q: How current is the data? A: openFDA data is typically updated weekly. The searchedAt timestamp in the report shows when the query was run.

Q: Why does metformin show CRITICAL risk? A: Metformin has 428K+ adverse event reports and 34K death-associated reports because it's one of the most widely prescribed drugs worldwide. High adverse event counts reflect high usage, not necessarily high danger. Always interpret in context.

Q: What's the difference between the domain-specific actors and this intelligence actor? A: The domain-specific actors (e.g., FDA Drug Recall Search) return detailed individual records with full field access and pagination. This actor returns a unified intelligence report combining aggregate statistics, risk assessment, and cross-domain timeline — optimized for decision-making rather than raw data extraction.

Q: Can I search for a specific recall number? A: This actor is designed for product/company intelligence. For specific recall lookup, use the individual FDA Drug Recall Search or FDA Medical Device Recall Search actors.

Q: How many API calls does one run make? A: Depends on scope. Drug-only: ~5 calls. Device-only: ~6 calls. All domains: ~15 calls. All calls run in parallel so wall-clock time is typically 2-5 seconds.

Related Actors

This actor aggregates data from the same sources as these individual actors in the FDA regulatory intelligence suite:

Use the individual actors when you need detailed records with full field access. Use this intelligence actor when you need a unified risk assessment and cross-domain overview.