# ClinicalTrials.gov & FDA openFDA Approvals, 510k & Recalls (`informed_almandine_vzb/clinical-trials-openfda-biotech-scraper`) Actor

Scrape ClinicalTrials.gov studies, sponsor contacts, FDA drug approvals (Drugs@FDA), 510(k) medical device clearances, and FDA recalls via openFDA.

- **URL**: https://apify.com/informed_almandine_vzb/clinical-trials-openfda-biotech-scraper.md
- **Developed by:** [Almandine Data](https://apify.com/informed_almandine_vzb) (community)
- **Categories:** Lead generation, AI, Business
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

$2.00 / 1,000 clinical trial or fda regulatory record scrapeds

This Actor is paid per event. You are not charged for the Apify platform usage, but only a fixed price for specific events.

Learn more: https://docs.apify.com/actors/running/actors-in-store.md#pay-per-event

## What's an Apify Actor?

An Actor is a serverless cloud program that runs on the Apify platform. It has two run modes.
In Batch mode, an Actor accepts a well-defined JSON input, performs an action which can take anything from a few seconds to a few hours,
and optionally produces a well-defined JSON output, datasets with results, or files in key-value store.
In Standby mode, an Actor provides a web server which can be used as a website, API, or an MCP server.

Apify vocabulary and the platform model are defined once, in the agent quickstart at https://apify.com/agents.md.

## How to integrate an Actor?

If asked about integration, you help developers integrate Actors into their projects.
You adapt to their stack and deliver integrations that are safe, well-documented, and production-ready.

Do not guess an integration path. Every one of them is in the agent quickstart at https://apify.com/agents.md: the Apify MCP server, Agent Skills with the Apify CLI, the JavaScript and Python clients, the REST API, and the account-free path for an agent with no human to sign in. It also carries the rule on stating cost before the first paid run.

For examples already wired to this Actor's own input schema, see the [API](#api) section below.

Each client library has reference documentation the quickstart does not restate: [JavaScript/TypeScript](https://docs.apify.com/api/client/js/docs.md) (`npm install apify-client`) and [Python](https://docs.apify.com/api/client/python/docs.md) (`pip install apify-client`).

# README

## ClinicalTrials.gov & FDA openFDA Approvals, 510k & Recalls

Scrape ClinicalTrials.gov studies, sponsor contacts, FDA drug approvals (Drugs@FDA), 510(k) medical device clearances, and FDA recalls via openFDA.

### What it does

Extracts and normalizes clinical trials from ClinicalTrials.gov (NCT IDs, phases, sponsors, enrollment, central contacts, trial locations) alongside official U.S. FDA drug approvals (Drugs@FDA NDA/ANDA/BLA), 510(k) medical device clearances, and FDA enforcement recalls (openFDA) in one unified dataset. Export clean, deduplicated data as **JSON, CSV, Excel, XML, or RSS**, or connect directly via the **Apify REST API, Python/JavaScript SDKs, CLI, MCP Server, Clay, n8n, Make, or Zapier** — with **no login, cookies, or browser overhead**.

### Use cases

- **CRO, eClinical & Patient Recruitment B2B Sales:** Identify newly registered `RECRUITING` and `NOT_YET_RECRUITING` Phase 1–3 biotech/pharma sponsors (`sponsorOrApplicant`, `leadContactName`, `leadContactEmail`, `leadContactPhone`) before trial sites finish enrollment.
- **MedTech & Medical Device Competitive Intelligence (`510(k)` Clearances):** Monitor FDA `510(k)` clearances (`fda_device_510k`) with `k_number`, `applicant`, `decision_date`, advisory committee specialty, and clearance decision summaries.
- **Biotech Hedge Fund, VC & Pharma Pipeline Tracking:** Track NDA/BLA/ANDA drug approvals (`fda_drug_approvals`), active ingredients, marketing statuses, and clinical trial completion timelines across oncology, metabolic (`glp-1`), and cardiovascular pipelines.
- **Quality Assurance, Supply Chain & Recall Alerts:** Stream Class I, II, and III FDA drug and medical device enforcement recalls (`fda_recalls`) with `recalling_firm` and `reason_for_recall`.

### Why use this scraper?

| Feature | This Actor | Generic Browser / HTML Scrapers |
|---|---|---|
| **Architecture** | Direct structured API / JSON / SSR requests (`curl_cffi`) | Heavy headless browser automation |
| **Speed & reliability** | **2–25 seconds** for 50–200 items | Minutes of high compute burn |
| **Pricing model** | **Pay per result (`$0.00` actor-start fee)** | Monthly rental or high CU overhead |
| **Error handling** | Failed inputs logged in `ERRORS` key-value record and **never charged** | Bills compute time even on failures |

### Input parameters

| Parameter | Type | Default | Description |
|---|---|---|---|
| `sources` | `array` | `["clinical_trials", "fda_drug_approvals", "fd...` | Data feeds to query and normalize ('clinical_trials' for ClinicalTrials.gov studies, 'fda_drug_approvals' for FDA Drugs@FDA NDA/ANDA/BLA approvals, 'fda_device_510k' for FDA 510(k) device clearances, 'fda_recalls' for FDA enforcement recalls). |
| `queries` | `array` | `["oncology", "glp-1", "cardiovascular"]` | Keywords, conditions, therapeutic areas, drug/device names, or sponsor companies to search. |
| `trialStatuses` | `array` | `["RECRUITING", "ACTIVE_NOT_RECRUITING", "COMP...` | Clinical trial recruitment status filter (e.g. 'RECRUITING', 'ACTIVE_NOT_RECRUITING', 'COMPLETED', 'NOT_YET_RECRUITING'). |
| `trialPhases` | `array` | `[]` | Optional filter by study phase (e.g. 'PHASE1', 'PHASE2', 'PHASE3', 'PHASE4'). Empty array returns all phases. |
| `onlyNew` | `boolean` | `false` | Deduplicate by NCTId, FDA application_number, 510(k) k_number, or recall_number across runs. |
| `maxItemsPerSource` | `integer` | `20` | Maximum number of records to extract per enabled feed (default 4 sources x 20 = 80 records). |
| `delaySeconds` | `number` | `0.2` | Polite pause between upstream HTTP requests (seconds). |

#### Parameter details

- **Biotech & regulatory feeds to extract** (`sources`, `array`): Data feeds to query and normalize ('clinical_trials' for ClinicalTrials.gov studies, 'fda_drug_approvals' for FDA Drugs@FDA NDA/ANDA/BLA approvals, 'fda_device_510k' for FDA 510(k) device clearances, 'fda_recalls' for FDA enforcement recalls).
- **Therapeutic areas, conditions, drug/device names, or sponsors** (`queries`, `array`): Keywords, conditions, therapeutic areas, drug/device names, or sponsor companies to search.
- **ClinicalTrials.gov status filter** (`trialStatuses`, `array`): Clinical trial recruitment status filter (e.g. 'RECRUITING', 'ACTIVE_NOT_RECRUITING', 'COMPLETED', 'NOT_YET_RECRUITING').
- **Clinical trial phases filter (optional)** (`trialPhases`, `array`): Optional filter by study phase (e.g. 'PHASE1', 'PHASE2', 'PHASE3', 'PHASE4'). Empty array returns all phases.
- **Only new records** (`onlyNew`, `boolean`): Deduplicate by NCTId, FDA application_number, 510(k) k_number, or recall_number across runs.
- **Max items per source** (`maxItemsPerSource`, `integer`): Maximum number of records to extract per enabled feed (default 4 sources x 20 = 80 records).
- **Delay between requests** (`delaySeconds`, `number`): Polite pause between requests (default `0.2`).

#### Example input

```json
{
  "sources": [
    "clinical_trials",
    "fda_drug_approvals",
    "fda_device_510k",
    "fda_recalls"
  ],
  "queries": [
    "oncology",
    "glp-1",
    "cardiovascular"
  ],
  "trialStatuses": [
    "RECRUITING",
    "ACTIVE_NOT_RECRUITING",
    "COMPLETED",
    "NOT_YET_RECRUITING"
  ],
  "trialPhases": [],
  "onlyNew": false,
  "maxItemsPerSource": 20
}
```

### Quickstart: API, Python & Automation (Clay / n8n / Make)

Run directly via the Apify REST API (`POST /v2/acts/informed_almandine_vzb~clinical-trials-openfda-biotech-scraper/runs`) or Python SDK:

```python
from apify_client import ApifyClient

client = ApifyClient("YOUR_APIFY_TOKEN")
run = client.actor("informed_almandine_vzb/clinical-trials-openfda-biotech-scraper").call(run_input={"sources": ["clinical_trials", "fda_drug_approvals", "fda_device_510k", "fda_recalls"], "queries": ["oncology", "glp-1", "cardiovascular"], "trialStatuses": ["RECRUITING", "ACTIVE_NOT_RECRUITING", "COMPLETED", "NOT_YET_RECRUITING"], "trialPhases": [], "onlyNew": false, "maxItemsPerSource": 20})
for item in client.dataset(run["defaultDatasetId"]).iterate_items():
    print(item)
```

### Output & example output

One dataset row per result. Default table view columns: `recordType, recordId, titleOrProductName, sponsorOrApplicant, statusOrDecision, phaseOrClassification, conditionsOrSpecialty, startDateOrDecisionDate, url`. Full structured JSON is stored in the run's default dataset.

#### Example output item

```json
{
  "recordType": "clinical_trial",
  "recordId": "NCT07893340",
  "titleOrProductName": "First-line Treatment With Dual Immunotherapy Combined With Anti-angiogenesis for Unresectable Advanced Malignant Peritoneal Mesothelioma",
  "sponsorOrApplicant": "Fudan University",
  "sponsorClass": "OTHER",
  "statusOrDecision": "NOT_YET_RECRUITING",
  "phaseOrClassification": "PHASE2",
  "conditionsOrSpecialty": "Peritoneal Mesothelioma, First-line Therapy",
  "interventionsOrIngredients": "Sintilimab, Ipilimumab N01, Bevacizumab",
  "enrollmentCount": 19,
  "startDateOrDecisionDate": "2026-10-30",
  "completionDate": "2030-09-30",
  "leadContactName": "Xiaodong Zhu",
  "leadContactEmail": "xddr001@163.com",
  "leadContactPhone": "18017312567",
  "locationsCount": 1,
  "summaryText": "This is a prospective, multicenter, single-arm, Phase II clinical study evaluating the efficacy and safety of sintilimab in combination with ipilimumab N01 and bevacizumab as fi...",
  "queryMatched": "oncology",
  "url": "https://clinicaltrials.gov/study/NCT07893340",
  "scrapedAt": "2026-10-25T16:20:20+00:00"
}
```

### Pricing (Pay-Per-Result)

This Actor uses transparent **Pay-Per-Event** pricing with a **`$0.00` actor-start fee**:

| Event | What is charged | Price |
|---|---|---|
| `biotech-record` | Clinical trial or FDA regulatory record scraped (One normalized ClinicalTrials.gov study or FDA openFDA approval, 510(k) clearance, or recall record) | **$0.002 / result** (**$2.00 / 1,000 results**) |
| `apify-actor-start` | Actor start fee | **$0.00** |

#### Concrete pricing math

- **`biotech-record` (Clinical trial or FDA regulatory record scraped):** `1,000 results = $2.00` (`50 results = $0.10`, `10,000 results = $20.00`). Apify's **$5.00/month Free Tier** covers up to **2,500 results/month** at **$0.00** out-of-pocket.
- **Empty runs (`0` results) & skipped duplicates (`onlyNew` / `onlyChanged`):** **$0.00**.

### Data and compliance

100% public U.S. federal biomedical and regulatory data: ClinicalTrials.gov internal study API (robots.txt explicitly states Allow: /api/int/) and the U.S. Food & Drug Administration openFDA REST API (CC0 public domain). Zero patient PHI. Requests are rate-limited and routed through Apify Proxy. Per-input errors are recorded in the run's `ERRORS` key-value record and are never charged.

### FAQ

**Do I need an account, login, or API key?**\
No. This Actor queries public endpoints directly and requires zero credentials.

**What happens if I start a run with empty `{}` input via API or CLI?**\
Every input defines identical `prefill` and `default` values in `.actor/input_schema.json`, so an empty `{}` run automatically returns **50+ live records** out of the box.

**How does incremental deduplication (`onlyNew`) work?**\
When `onlyNew: true` is enabled, the Actor stores seen record IDs in a named Apify Key-Value Store (`clinical-trials-fda-intel-state`) and emits only newly discovered records on subsequent scheduled runs.

**Can I export to CSV, Excel, Google Sheets, Clay, or n8n?**\
Yes. Every dataset item uses flat, normalized top-level keys (`recordType, recordId, titleOrProductName, sponsorOrApplicant, statusOrDecision, phaseOrClassification`, etc.) for one-click CSV/Excel download or native webhook delivery.

# Actor input Schema

## `sources` (type: `array`):

Data feeds to query and normalize ('clinical_trials' for ClinicalTrials.gov studies, 'fda_drug_approvals' for FDA Drugs@FDA NDA/ANDA/BLA approvals, 'fda_device_510k' for FDA 510(k) device clearances, 'fda_recalls' for FDA enforcement recalls).

## `queries` (type: `array`):

Keywords, conditions, therapeutic areas, drug/device names, or sponsor companies to search.

## `trialStatuses` (type: `array`):

Clinical trial recruitment status filter (e.g. 'RECRUITING', 'ACTIVE_NOT_RECRUITING', 'COMPLETED', 'NOT_YET_RECRUITING').

## `trialPhases` (type: `array`):

Optional filter by study phase (e.g. 'PHASE1', 'PHASE2', 'PHASE3', 'PHASE4'). Empty array returns all phases.

## `onlyNew` (type: `boolean`):

Deduplicate by NCTId, FDA application_number, 510(k) k_number, or recall_number across runs.

## `maxItemsPerSource` (type: `integer`):

Maximum number of records to extract per enabled feed (default 4 sources x 20 = 80 records).

## `delaySeconds` (type: `number`):

Polite pause between requests.

## `proxyConfiguration` (type: `object`):

Apify Proxy settings.

## Actor input object example

```json
{
  "sources": [
    "clinical_trials",
    "fda_drug_approvals",
    "fda_device_510k",
    "fda_recalls"
  ],
  "queries": [
    "oncology",
    "glp-1",
    "cardiovascular"
  ],
  "trialStatuses": [
    "RECRUITING",
    "ACTIVE_NOT_RECRUITING",
    "COMPLETED",
    "NOT_YET_RECRUITING"
  ],
  "trialPhases": [],
  "onlyNew": false,
  "maxItemsPerSource": 20,
  "delaySeconds": 0.2,
  "proxyConfiguration": {
    "useApifyProxy": true
  }
}
```

# Actor output Schema

## `overview` (type: `string`):

No description

## `results` (type: `string`):

No description

# API

You can run this Actor programmatically using our API. Below are code examples in JavaScript, Python, and CLI, as well as the OpenAPI specification and MCP server setup.

## JavaScript example

```javascript
import { ApifyClient } from 'apify-client';

// Initialize the ApifyClient with your Apify API token
// Replace the '<YOUR_API_TOKEN>' with your token
const client = new ApifyClient({
    token: '<YOUR_API_TOKEN>',
});

// Prepare Actor input
const input = {
    "sources": [
        "clinical_trials",
        "fda_drug_approvals",
        "fda_device_510k",
        "fda_recalls"
    ],
    "queries": [
        "oncology",
        "glp-1",
        "cardiovascular"
    ],
    "trialStatuses": [
        "RECRUITING",
        "ACTIVE_NOT_RECRUITING",
        "COMPLETED",
        "NOT_YET_RECRUITING"
    ],
    "trialPhases": [],
    "onlyNew": false,
    "maxItemsPerSource": 20
};

// Run the Actor and wait for it to finish
const run = await client.actor("informed_almandine_vzb/clinical-trials-openfda-biotech-scraper").call(input);

// Fetch and print Actor results from the run's dataset (if any)
console.log('Results from dataset');
console.log(`💾 Check your data here: https://console.apify.com/storage/datasets/${run.defaultDatasetId}`);
const { items } = await client.dataset(run.defaultDatasetId).listItems();
items.forEach((item) => {
    console.dir(item);
});

// 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/js/docs

```

## Python example

```python
from apify_client import ApifyClient

# Initialize the ApifyClient with your Apify API token
# Replace '<YOUR_API_TOKEN>' with your token.
client = ApifyClient("<YOUR_API_TOKEN>")

# Prepare the Actor input
run_input = {
    "sources": [
        "clinical_trials",
        "fda_drug_approvals",
        "fda_device_510k",
        "fda_recalls",
    ],
    "queries": [
        "oncology",
        "glp-1",
        "cardiovascular",
    ],
    "trialStatuses": [
        "RECRUITING",
        "ACTIVE_NOT_RECRUITING",
        "COMPLETED",
        "NOT_YET_RECRUITING",
    ],
    "trialPhases": [],
    "onlyNew": False,
    "maxItemsPerSource": 20,
}

# Run the Actor and wait for it to finish
run = client.actor("informed_almandine_vzb/clinical-trials-openfda-biotech-scraper").call(run_input=run_input)

# Fetch and print Actor results from the run's dataset (if there are any)
print(f"💾 Check your data here: https://console.apify.com/storage/datasets/{run.default_dataset_id}")
for item in client.dataset(run.default_dataset_id).iterate_items():
    print(item)

# 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/python/docs/quick-start

```

## CLI example

```bash
echo '{
  "sources": [
    "clinical_trials",
    "fda_drug_approvals",
    "fda_device_510k",
    "fda_recalls"
  ],
  "queries": [
    "oncology",
    "glp-1",
    "cardiovascular"
  ],
  "trialStatuses": [
    "RECRUITING",
    "ACTIVE_NOT_RECRUITING",
    "COMPLETED",
    "NOT_YET_RECRUITING"
  ],
  "trialPhases": [],
  "onlyNew": false,
  "maxItemsPerSource": 20
}' |
apify call informed_almandine_vzb/clinical-trials-openfda-biotech-scraper --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,informed_almandine_vzb/clinical-trials-openfda-biotech-scraper"
        }
    }
}
```

The hosted server signs you in with OAuth on first connect, so no API token belongs in this config. Clients without OAuth support can send an `Authorization: Bearer <APIFY_API_TOKEN>` header instead, using a token from API & Integrations in Apify Console (https://console.apify.com/settings/integrations).

## OpenAPI specification

Download the OpenAPI definition: https://api.apify.com/v2/actors/YOXHiZ8kV7RUEoVRY/builds/Bz2ewOboVfuKkS209/openapi.json