# openFDA Approvals Monitor (`bytehavenstudios/openfda-approvals-monitor`) Actor Change-detection over the FDA approval and clearance stream: new drug approvals (Drugs@FDA), device 510(k) clearances and PMA approvals, unified into one normalized approval record (regulator, applicant, product, date, pathway). Filter by applicant, endpoint or date. Keyless, CC0. - **URL**: https://apify.com/bytehavenstudios/openfda-approvals-monitor.md - **Developed by:** [ByteHaven Studios](https://apify.com/bytehavenstudios) (community) - **Categories:** Developer tools, News - **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks - **User rating**: No ratings yet ## Pricing from $10.00 / 1,000 approval returneds 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/platform/actors/running/actors-in-store#pay-per-event ## What's an Apify Actor? Actors are a software tools running on the Apify platform, for all kinds of web data extraction and automation use cases. 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. Actors are written with capital "A". ## 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. The best way to integrate Actors is as follows. In JavaScript/TypeScript projects, use official [JavaScript/TypeScript client](https://docs.apify.com/api/client/js.md): ```bash npm install apify-client ``` In Python projects, use official [Python client library](https://docs.apify.com/api/client/python.md): ```bash pip install apify-client ``` In shell scripts, use [Apify CLI](https://docs.apify.com/cli/docs.md): ````bash # MacOS / Linux curl -fsSL https://apify.com/install-cli.sh | bash # Windows irm https://apify.com/install-cli.ps1 | iex ```bash In AI frameworks, you might use the [Apify MCP server](https://docs.apify.com/platform/integrations/mcp.md). If your project is in a different language, use the [REST API](https://docs.apify.com/api/v2.md). For usage examples, see the [API](#api) section below. For more details, see Apify documentation as [Markdown index](https://docs.apify.com/llms.txt) and [Markdown full-text](https://docs.apify.com/llms-full.txt). # README ## openFDA Approvals Monitor **First-seen change-detection over the FDA approval/clearance stream.** One run watches three regulatory silos at once — new **drug approvals** (Drugs@FDA), device **510(k) clearances**, and device **PMA approvals** — and folds their heterogeneous schemas into ONE normalized `approval` record (regulator, applicant, product, approval date, pathway = NDA/ANDA/BLA/510k/PMA). Filter by applicant (competitor watch), device product code, endpoint, or date window; a **new-since-last-run** mode keeps a per-endpoint high-water-mark and emits each newly-appeared approval once. Clean REST/JSON — no browser, no proxy, no login, no API key required. **Data source: openFDA (FDA), U.S. public domain, CC0 1.0 Universal.** > This product uses data from the U.S. FDA openFDA API (public domain, CC0 1.0). It is not endorsed > or certified by the FDA and is not a substitute for the official FDA approval/clearance records. > **Status: launch-ready (v0.1), unpublished.** The runtime (`src/openfda.js`, `src/filters.js`, > `src/main.js`) and its offline test suite are complete; the Actor is **not** published to the Apify > Store and no on-platform price is set (see `docs/PRICING.md`). See `CHANGELOG.md` for detail. --- ### What it does For each run it queries the selected openFDA approval endpoints over a date window (`api.fda.gov/drug/drugsfda.json`, `/device/510k.json`, `/device/pma.json`), normalizes every raw record into one flat `approval` shape, dedupes on the endpoint-appropriate key, keeps only approvals dated after the last-run per-endpoint high-water-mark, and pushes one dataset item per approval. - **Cross-silo normalization** (the moat): content farms scrape drug labels and adverse-events in bulk; nobody unifies the **first-seen approval/clearance stream** across the drug and device silos into one comparable record. This does exactly that — "what got approved this week", filterable. - **Applicant / product-code filter**: watch a competitor's approvals, or a device product code. - **Pathway classification**: each record carries `pathway` (NDA / ANDA / BLA / 510k / PMA). - **New-approval monitor**: `monitorNewOnly` persists the max approval date per endpoint (in the Actor's key-value store) and, on the next scheduled run, emits only approvals dated after it. ### Inputs | Input | Type | Notes | |---|---|---| | `endpoints` | string[] | Which streams: `drug`, `510k`, `pma`. Empty = all three (cross-silo moat) | | `applicants` | string[] | Optional applicant/sponsor substrings (competitor watch). Empty = all | | `productCodes` | string[] | Optional device product codes (510k/PMA only). Empty = all | | `approvedSince` | string | Approval-date lower bound (YYYY-MM-DD). Empty = recent trailing window | | `approvedUntil` | string | Optional approval-date upper bound (YYYY-MM-DD). Empty = up to today | | `monitorNewOnly` | boolean | Emit only approvals after the stored per-endpoint high-water-mark | | `fields` | string[] | Optional override of kept fields (see default set below). Empty = default | | `maxResults` | integer | Cap total approvals returned across endpoints (0 = no cap) | | `apiKey` | string | Optional free openFDA api_key (raises daily rate limit; not required) | | `proxyConfiguration` | object | Optional; the API is open and needs no proxy. Default: none | ### Output — one record per approval (intended shape) ```json { "approvalId": "K033177", "endpoint": "510k", "regulator": "FDA", "center": "CDRH", "pathway": "510k", "applicant": "Acme Medical Inc.", "productName": "Acme Glucose Meter", "productCode": "NBW", "applicationNumber": null, "activeIngredients": null, "advisoryCommittee": "CH", "decisionCode": "SESE", "decisionDescription": "Substantially Equivalent", "approvalDate": "2026-07-08", "isNew": true, "attribution": "This product uses data from the U.S. FDA openFDA API (public domain, CC0 1.0). It is not endorsed or certified by the FDA and is not a substitute for the official FDA approval/clearance records.", "fetchedAt": "2026-07-10T14:00:00.000Z" } ```` `approvalId` is the endpoint-appropriate dedupe key — `k_number` (510k), `pma_number`+`supplement_number` (PMA), or `application_number`+submission (drug). Drug records instead carry `applicationNumber` + `activeIngredients` + `productName` (brand name) with `pathway` NDA/ANDA/BLA; device records carry `productCode` + `decisionCode`. Absent fields are `null`. `isNew` is `true` when an approval was not seen in a previous run (only meaningful with `monitorNewOnly`). Every record carries the courtesy `attribution` disclaimer. #### Control records (not charged) Two non-approval records may be pushed to signal run state. Neither triggers an `approval-returned` charge: | Record | When | Shape | |---|---|---| | `_noData` | No approvals matched the endpoint/filter/window | `{ "_noData": true, "filters": {...}, "message": "...", "fetchedAt": "..." }` | | `_error` | The fetch failed after retries, or normalization threw | `{ "_error": true, "filters": {...}, "message": "...", "fetchedAt": "..." }` | `_noData` keeps a zero-result run green and auditable rather than pushing a silent empty dataset. ### Pricing (pay-per-event) One **`approval-returned`** event is charged per approval record pushed to the dataset. Cost scales with results, not runtime. Use `endpoints` / `applicants` / `productCodes` / `maxResults` / `monitorNewOnly` to keep spend proportional to signal. (Live price shown on the Store page; the pricing model + reasoning are in [`docs/PRICING.md`](./docs/PRICING.md).) ### Data source & attribution openFDA content and data are **public domain under a Creative Commons CC0 1.0 Universal dedication** — free to copy, modify and redistribute, including commercially, without asking permission. No key and no attribution are required; we credit the FDA / openFDA as a courtesy and surface a no-endorsement disclaimer on every record. Full compliance record: [`COMPLIANCE.md`](./COMPLIANCE.md). > openFDA is a research/informational service; approval data may be incomplete or lag the FDA's own > systems and is **not** a substitute for the official Drugs@FDA / 510(k) / PMA databases. This Actor > relays the data as published; it does not certify accuracy. ### Maintenance notes - **Three schemas, two date semantics.** Drug records are a nested `submissions[]` array with a compact `YYYYMMDD` `submission_status_date`; a "new approval" is the first `AP` submission. Device records (510k/PMA) are flat with an ISO `decision_date`. The normalizer folds all three into one `approval` shape defensively (optional chaining, not fixed indexes). - **Dedupe keys differ.** 510(k) = `k_number` (globally unique); PMA = `pma_number` + `supplement_number`; drug = `application_number` + submission\_type + submission\_number. The normalizer builds the endpoint-appropriate `approvalId`. - **Query-based, not a firehose.** openFDA has no "approvals since date X" endpoint — the delta is emulated per endpoint by a date-range `search` from the stored watermark, paged newest-first. - **Paging ceilings** — `limit` ≤ 1000, `skip` ≤ 25,000; wide windows must switch to `search_after` or split the date range. openFDA answers a zero-match query with **HTTP 404** (not an empty list) — treat as "no data", not an error. - **Weekly `last_updated` cadence** — approvals post in weekly batches, so a monitoring schedule should overlap its date window run-to-run to avoid missing a late-posted approval. - **Rate limits** — keyless is 240 req/min and 1000/day per IP; an optional free `apiKey` raises the daily cap to 120,000. Large historical pulls should throttle and back off on `429`. - **Courtesy `User-Agent`** — not mandated, but sent on every request (`USER_AGENT` const). # Actor input Schema ## `endpoints` (type: `array`): Which openFDA approval endpoints to query. drug = /drug/drugsfda.json (new drug approvals — first `AP` submission), 510k = /device/510k.json (device 510(k) clearances), pma = /device/pma.json (device PMA approvals + supplements). Empty = all three (the cross-silo moat). ## `applicants` (type: `array`): Optional. Restrict to approvals whose applicant/sponsor matches one of these names (case-insensitive substring, e.g. "Pfizer", "Medtronic"). Matched against the drug `sponsor_name` and the device `applicant`. Empty = all applicants (competitor-watch is opt-in). ## `productCodes` (type: `array`): Optional. Restrict device (510k / PMA) approvals to these FDA product codes (3-letter codes, e.g. "DXN", "OZO"). Ignored for the drug endpoint. Empty = all product codes. ## `approvedSince` (type: `string`): Only return approvals dated on/after this date. Maps to the openFDA date-range search per endpoint (drug: submissions.submission\_status\_date; device: decision\_date). Leave empty to default to a recent trailing window. Ignored if 'Only new since last run' is on (the stored per-endpoint watermark drives the window instead). ## `approvedUntil` (type: `string`): Optional upper bound on the approval/decision date. Leave empty for no upper bound (up to today). ## `monitorNewOnly` (type: `boolean`): Persist a per-endpoint high-water-mark (the max approval date seen, in the Actor's key-value store) and, on the next run, emit only approvals dated after it. Turns this Actor into a first-seen new-approval monitor across scheduled runs. ## `fields` (type: `array`): Optional. Override the set of fields kept on each normalized approval record. Empty = a sensible default set (see README). Applied client-side (openFDA does not project the approval endpoints server-side). ## `maxResults` (type: `integer`): Cap the total number of approvals returned (across all selected endpoints). 0 = no cap (paginate to openFDA's per-query ceiling, windowing dates as needed). ## `apiKey` (type: `string`): Optional free openFDA api\_key. Keyless access allows 240 requests/min and 1000/day per IP; a key raises the daily limit to 120,000. Not required for typical scheduled runs. Get one at https://open.fda.gov/apis/authentication/. ## `proxyConfiguration` (type: `object`): Optional. The openFDA API is a clean, open, public endpoint and needs NO proxy. You may enable Apify Proxy only to distribute requests if you run very large historical pulls. Default: no proxy. ## Actor input object example ```json { "endpoints": [ "drug", "510k", "pma" ], "applicants": [], "productCodes": [], "approvedSince": "2026-07-01", "approvedUntil": "2026-07-10", "monitorNewOnly": false, "fields": [], "maxResults": 0, "proxyConfiguration": { "useApifyProxy": false } } ``` # Actor output Schema ## `approvals` (type: `string`): One item per FDA approval or clearance (drug approval, 510(k) clearance, or PMA approval), normalized into a single record. Rendered as the Approvals table (see the dataset schema). # 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 '' with your token const client = new ApifyClient({ token: '', }); // Prepare Actor input const input = { "endpoints": [ "drug", "510k", "pma" ], "applicants": [], "productCodes": [], "fields": [] }; // Run the Actor and wait for it to finish const run = await client.actor("bytehavenstudios/openfda-approvals-monitor").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 '' with your token. client = ApifyClient("") # Prepare the Actor input run_input = { "endpoints": [ "drug", "510k", "pma", ], "applicants": [], "productCodes": [], "fields": [], } # Run the Actor and wait for it to finish run = client.actor("bytehavenstudios/openfda-approvals-monitor").call(run_input=run_input) # Fetch and print Actor results from the run's dataset (if there are any) print("💾 Check your data here: https://console.apify.com/storage/datasets/" + run["defaultDatasetId"]) for item in client.dataset(run["defaultDatasetId"]).iterate_items(): print(item) # 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/python/docs/quick-start ``` ## CLI example ```bash echo '{ "endpoints": [ "drug", "510k", "pma" ], "applicants": [], "productCodes": [], "fields": [] }' | apify call bytehavenstudios/openfda-approvals-monitor --silent --output-dataset ``` ## MCP server setup ```json { "mcpServers": { "apify": { "command": "npx", "args": [ "mcp-remote", "https://mcp.apify.com/?tools=bytehavenstudios/openfda-approvals-monitor", "--header", "Authorization: Bearer " ] } } } ``` ## OpenAPI specification ```json { "openapi": "3.0.1", "info": { "title": "openFDA Approvals Monitor", "description": "Change-detection over the FDA approval and clearance stream: new drug approvals (Drugs@FDA), device 510(k) clearances and PMA approvals, unified into one normalized approval record (regulator, applicant, product, date, pathway). Filter by applicant, endpoint or date. Keyless, CC0.", "version": "0.1", "x-build-id": "uQ7T2iS2tRIqbpZKl" }, "servers": [ { "url": "https://api.apify.com/v2" } ], "paths": { "/acts/bytehavenstudios~openfda-approvals-monitor/run-sync-get-dataset-items": { "post": { "operationId": "run-sync-get-dataset-items-bytehavenstudios-openfda-approvals-monitor", "x-openai-isConsequential": false, "summary": "Executes an Actor, waits for its completion, and returns Actor's dataset items in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK" } } } }, "/acts/bytehavenstudios~openfda-approvals-monitor/runs": { "post": { "operationId": "runs-sync-bytehavenstudios-openfda-approvals-monitor", "x-openai-isConsequential": false, "summary": "Executes an Actor and returns information about the initiated run in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK", "content": { "application/json": { "schema": { "$ref": "#/components/schemas/runsResponseSchema" } } } } } } }, "/acts/bytehavenstudios~openfda-approvals-monitor/run-sync": { "post": { "operationId": "run-sync-bytehavenstudios-openfda-approvals-monitor", "x-openai-isConsequential": false, "summary": "Executes an Actor, waits for completion, and returns the OUTPUT from Key-value store in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK" } } } } }, "components": { "schemas": { "inputSchema": { "type": "object", "properties": { "endpoints": { "title": "Approval streams", "type": "array", "description": "Which openFDA approval endpoints to query. drug = /drug/drugsfda.json (new drug approvals — first `AP` submission), 510k = /device/510k.json (device 510(k) clearances), pma = /device/pma.json (device PMA approvals + supplements). Empty = all three (the cross-silo moat).", "items": { "type": "string", "enum": [ "drug", "510k", "pma" ], "enumTitles": [ "Drug approvals (Drugs@FDA)", "Device 510(k) clearances", "Device PMA approvals" ] } }, "applicants": { "title": "Applicants / sponsors to watch", "type": "array", "description": "Optional. Restrict to approvals whose applicant/sponsor matches one of these names (case-insensitive substring, e.g. \"Pfizer\", \"Medtronic\"). Matched against the drug `sponsor_name` and the device `applicant`. Empty = all applicants (competitor-watch is opt-in).", "items": { "type": "string" } }, "productCodes": { "title": "Device product codes to watch", "type": "array", "description": "Optional. Restrict device (510k / PMA) approvals to these FDA product codes (3-letter codes, e.g. \"DXN\", \"OZO\"). Ignored for the drug endpoint. Empty = all product codes.", "items": { "type": "string" } }, "approvedSince": { "title": "Approved on/after (YYYY-MM-DD)", "type": "string", "description": "Only return approvals dated on/after this date. Maps to the openFDA date-range search per endpoint (drug: submissions.submission_status_date; device: decision_date). Leave empty to default to a recent trailing window. Ignored if 'Only new since last run' is on (the stored per-endpoint watermark drives the window instead)." }, "approvedUntil": { "title": "Approved on/before (optional upper bound, YYYY-MM-DD)", "type": "string", "description": "Optional upper bound on the approval/decision date. Leave empty for no upper bound (up to today)." }, "monitorNewOnly": { "title": "Only new since last run", "type": "boolean", "description": "Persist a per-endpoint high-water-mark (the max approval date seen, in the Actor's key-value store) and, on the next run, emit only approvals dated after it. Turns this Actor into a first-seen new-approval monitor across scheduled runs.", "default": false }, "fields": { "title": "Fields to keep", "type": "array", "description": "Optional. Override the set of fields kept on each normalized approval record. Empty = a sensible default set (see README). Applied client-side (openFDA does not project the approval endpoints server-side).", "items": { "type": "string" } }, "maxResults": { "title": "Max approvals per run", "minimum": 0, "type": "integer", "description": "Cap the total number of approvals returned (across all selected endpoints). 0 = no cap (paginate to openFDA's per-query ceiling, windowing dates as needed).", "default": 0 }, "apiKey": { "title": "openFDA API key (optional)", "type": "string", "description": "Optional free openFDA api_key. Keyless access allows 240 requests/min and 1000/day per IP; a key raises the daily limit to 120,000. Not required for typical scheduled runs. Get one at https://open.fda.gov/apis/authentication/." }, "proxyConfiguration": { "title": "Proxy configuration", "type": "object", "description": "Optional. The openFDA API is a clean, open, public endpoint and needs NO proxy. You may enable Apify Proxy only to distribute requests if you run very large historical pulls. Default: no proxy.", "default": { "useApifyProxy": false } } } }, "runsResponseSchema": { "type": "object", "properties": { "data": { "type": "object", "properties": { "id": { "type": "string" }, "actId": { "type": "string" }, "userId": { "type": "string" }, "startedAt": { "type": "string", "format": "date-time", "example": "2025-01-08T00:00:00.000Z" }, "finishedAt": { "type": "string", "format": "date-time", "example": "2025-01-08T00:00:00.000Z" }, "status": { "type": "string", "example": "READY" }, "meta": { "type": "object", "properties": { "origin": { "type": "string", "example": "API" }, "userAgent": { "type": "string" } } }, "stats": { "type": "object", "properties": { "inputBodyLen": { "type": "integer", "example": 2000 }, "rebootCount": { "type": "integer", "example": 0 }, "restartCount": { "type": "integer", "example": 0 }, "resurrectCount": { "type": "integer", "example": 0 }, "computeUnits": { "type": "integer", "example": 0 } } }, "options": { "type": "object", "properties": { "build": { "type": "string", "example": "latest" }, "timeoutSecs": { "type": "integer", "example": 300 }, "memoryMbytes": { "type": "integer", "example": 1024 }, "diskMbytes": { "type": "integer", "example": 2048 } } }, "buildId": { "type": "string" }, "defaultKeyValueStoreId": { "type": "string" }, "defaultDatasetId": { "type": "string" }, "defaultRequestQueueId": { "type": "string" }, "buildNumber": { "type": "string", "example": "1.0.0" }, "containerUrl": { "type": "string" }, "usage": { "type": "object", "properties": { "ACTOR_COMPUTE_UNITS": { "type": "integer", "example": 0 }, "DATASET_READS": { "type": "integer", "example": 0 }, "DATASET_WRITES": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_READS": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_WRITES": { "type": "integer", "example": 1 }, "KEY_VALUE_STORE_LISTS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_READS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_WRITES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_INTERNAL_GBYTES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_EXTERNAL_GBYTES": { "type": "integer", "example": 0 }, "PROXY_RESIDENTIAL_TRANSFER_GBYTES": { "type": "integer", "example": 0 }, "PROXY_SERPS": { "type": "integer", "example": 0 } } }, "usageTotalUsd": { "type": "number", "example": 0.00005 }, "usageUsd": { "type": "object", "properties": { "ACTOR_COMPUTE_UNITS": { "type": "integer", "example": 0 }, "DATASET_READS": { "type": "integer", "example": 0 }, "DATASET_WRITES": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_READS": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_WRITES": { "type": "number", "example": 0.00005 }, "KEY_VALUE_STORE_LISTS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_READS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_WRITES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_INTERNAL_GBYTES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_EXTERNAL_GBYTES": { "type": "integer", "example": 0 }, "PROXY_RESIDENTIAL_TRANSFER_GBYTES": { "type": "integer", "example": 0 }, "PROXY_SERPS": { "type": "integer", "example": 0 } } } } } } } } } } ```