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

{
  "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:

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

{
  "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.