# FDA Drug Approval & Recall Watch — Pharma Monitor (`azureblue/fda-drug-approval-watch`) Actor

Daily delta monitor of FDA drug approvals (Drugs@FDA) and drug recalls (openFDA enforcement) — for Pharma Regulatory, Pharmacovigilance, and US market access teams. Webhook-ready alerts.

- **URL**: https://apify.com/azureblue/fda-drug-approval-watch.md
- **Developed by:** [azureblue](https://apify.com/azureblue) (community)
- **Categories:** Developer tools
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, NaN bookmarks
- **User rating**: No ratings yet

## Pricing

Pay per event

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

## FDA Drug Approval & Recall Watch — Daily Pharma Monitor

**Daily delta monitor of FDA drug approvals (Drugs@FDA) and drug recalls (openFDA enforcement) — for Pharma Regulatory Affairs, Pharmacovigilance, and US Market Access teams.**

Webhook-ready alerts in seconds. Unified output schema with our EU regulator monitors so you can join FDA + EMA + MHRA in one query.

---

### What this Actor does

On each scheduled run:

1. Queries **openFDA `/drug/drugsfda.json`** for the last 90 days of NDA/ANDA/BLA submissions with status `AP` (approved).
2. Queries **openFDA `/drug/enforcement.json`** for the last 90 days of drug recalls (Class I/II/III).
3. Computes a stable identity per record (NDA + submission + status, OR recall number + status) and **diffs against the seen-set in its KV store**.
4. Pushes only **new or changed** records to the dataset — never duplicates.
5. Optionally fires a **HMAC-signed webhook** for every new alert.
6. Charges once per calendar month (subscription) plus per-alert.

---

### Use Cases

#### 1. Pharma Pharmacovigilance — react to Class I recalls within minutes
A PV team subscribes with `recallClassFilter: ["Class I"]` and a Slack webhook. The moment FDA publishes a Class I recall on a competitor's product (or worse, their own), Slack pings the on-call PV lead with the openFDA URL pre-resolved. **From regulator publication to internal alert: under 60 seconds vs. ~24h via daily email digests.**

#### 2. US Market Access — track every NDA/BLA approval in indication
A US market-access analyst monitors first-in-class and follow-on approvals: `sources: ["approvals"]`. Each new approval flows into their internal pipeline tracker with sponsor + dosage form + approval-class-code. **Saves 6-10 hours/week of manual Drugs@FDA portal-trawling.**

#### 3. Regulatory CI — monitor competitor sNDAs / supplemental approvals
A regulatory CI specialist filters on a known competitor's NDA list (post-process) to detect supplemental applications (sNDA) — labelling changes, new indications, new pediatric studies. Identifies competitor lifecycle moves **2-4 weeks before press release**.

---

### Output

Every dataset item conforms to the unified `RegulatorAlert` schema shared across this publisher's Tier-A monitoring actors. Drop into your warehouse alongside EMA / MHRA / Swissmedic outputs — same column layout, same field semantics.

#### Example item — Class I recall

```json
{
  "scrapedAt": "2026-05-07T07:00:00.000Z",
  "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1234-2026",
  "sourceDomain": "accessdata.fda.gov",
  "actorVersion": "1.0.0",
  "dataHash": "8a2f...d0",

  "regulator": "FDA",
  "alertType": "recall",
  "recordId": "D-1234-2026",
  "changeKind": "new",

  "productName": "AcmePharm Insulin 100 IU/mL",
  "activeSubstance": "insulin lispro",
  "inn": "insulin lispro",
  "atcCode": null,
  "manufacturer": "AcmePharm Inc.",
  "therapeuticArea": null,
  "indication": null,

  "publishedAt": "2026-05-06",
  "effectiveAt": "2026-05-04",
  "severity": "critical",
  "summary": "Class I: AcmePharm Insulin 100 IU/mL recall. Reason: mislabeling — vials labelled as 100 IU/mL contain 50 IU/mL.",
  "rawSnippet": "AcmePharm Insulin 100 IU/mL, 10 mL vials, lots 12345...",

  "documents": [{ "kind": "FDA-recall", "url": "https://...", "title": "D-1234-2026" }],
  "extras": {
    "recallNumber": "D-1234-2026",
    "classification": "Class I",
    "status": "Ongoing",
    "voluntary": "Voluntary",
    "distribution": "Nationwide"
  }
}
````

#### Webhook payload

If you set `webhookUrl`:

```json
{
  "eventId": "8a2f...d0",
  "eventType": "fda.recall",
  "actor": "fda-drug-approval-watch",
  "emittedAt": "2026-05-07T07:00:01.123Z",
  "schemaVersion": 1,
  "data": { /* the alert object above */ }
}
```

`X-Azureblue-Signature: sha256=<hex>` header included if `webhookSecret` is set.

***

### Pricing

| Event | Charge | When it fires |
|---|---|---|
| **Monthly subscription** | **$79** | Once per calendar month per user, on first delta-mode run |
| **Per alert** | **$0.02** | Per new/changed approval or recall pushed to the dataset |

Typical pharma PV buyer: ~10-30 alerts/month → **$79 + ~$0.40/mo ≈ $80/mo all-in**. Compare to a single missed Class I recall costing $1M+ in remediation.

**Trial mode** (`mode: "trial"`) returns 5 results, no charges, no state writes.

***

### Compliance

- **Public-data only** — sourced from openFDA (https://api.fda.gov), the FDA's official open-data interface. No login, no scraping of paywalled endpoints.
- **No PHI** — Drugs@FDA + recall enforcement are product-level metadata, not patient records.
- **GDPR Art. 6(1)(f) / US public-records law** — buyer is responsible for downstream use of the data.
- **Audit log** — every fetch recorded in the actor's KV store (URL + timestamp, PII-redacted).

***

### Sister Actors — same publisher, complementary coverage

- [`ema-drug-approval-watch`](https://apify.com/azureblue/ema-drug-approval-watch) — same alert schema, EMA EPAR side
- [`bfarm-pei-pharmacovigilance-monitor`](https://apify.com/azureblue/bfarm-pei-pharmacovigilance-monitor) — German PV (Rote-Hand-Briefe, BfArM, PEI)
- [`medical-device-recall-scraper`](https://apify.com/azureblue/medical-device-recall-scraper) — FDA medical-device recalls (separate from drug recalls)
- [`drug-interaction-checker`](https://apify.com/azureblue/drug-interaction-checker) — RxNorm-based pairwise drug interaction lookup
- [`pubmed-abstract-scraper`](https://apify.com/azureblue/pubmed-abstract-scraper) — PubMed metadata for the products in your alert stream

***

### Changelog

See `CHANGELOG.md`.

# Actor input Schema

## `mode` (type: `string`):

Delta returns only new entries since the last run. Snapshot rebuilds the full baseline. Trial returns the first 5 results with no charges — start here to evaluate. Pricing is pay-per-result ($0.02/result); there is no subscription fee.

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

Allowed values: "approvals" (Drugs@FDA submissions, status AP) and "recalls" (openFDA drug enforcement). Pick one or both. Other strings are silently ignored.

## `recallClassFilter` (type: `array`):

Allowed values: "Class I" (high-severity), "Class II" (temporary/reversible), "Class III" (unlikely harm). Most CI buyers want Class I + II only.

## `webhookUrl` (type: `string`):

POST endpoint that receives one JSON payload per new alert. Test with https://webhook.site to inspect payloads. Failed deliveries land in the actor's KV store under `webhook.dlq.*` for replay.

## `webhookSecret` (type: `string`):

If set, every webhook request includes `X-Azureblue-Signature: sha256=<hex>` so your endpoint can verify.

## `maxResults` (type: `integer`):

Cap on how many alerts the run pushes to the dataset. Default 50 — sized for a daily delta run (a typical day yields 5–30 new FDA items) and keeps per-run cost low (~$1.00 at $0.02/result). Raise it (up to 5000) for a full 90-day baseline rebuild — note that a baseline of the entire window can cost $4+ and may exceed the per-run cost cap on a low-balance account.

## Actor input object example

```json
{
  "mode": "trial",
  "sources": [
    "approvals",
    "recalls"
  ],
  "recallClassFilter": [
    "Class I",
    "Class II",
    "Class III"
  ],
  "maxResults": 50
}
```

# Actor output Schema

## `dataset` (type: `string`):

Run's default dataset — every new approval / recall as a separate item.

# 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 = {
    "mode": "trial"
};

// Run the Actor and wait for it to finish
const run = await client.actor("azureblue/fda-drug-approval-watch").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 = { "mode": "trial" }

# Run the Actor and wait for it to finish
run = client.actor("azureblue/fda-drug-approval-watch").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 '{
  "mode": "trial"
}' |
apify call azureblue/fda-drug-approval-watch --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "command": "npx",
            "args": [
                "mcp-remote",
                "https://mcp.apify.com/?tools=azureblue/fda-drug-approval-watch",
                "--header",
                "Authorization: Bearer <YOUR_API_TOKEN>"
            ]
        }
    }
}

```

## OpenAPI specification

```json
{
    "openapi": "3.0.1",
    "info": {
        "title": "FDA Drug Approval & Recall Watch — Pharma Monitor",
        "description": "Daily delta monitor of FDA drug approvals (Drugs@FDA) and drug recalls (openFDA enforcement) — for Pharma Regulatory, Pharmacovigilance, and US market access teams. Webhook-ready alerts.",
        "version": "1.0",
        "x-build-id": "CvqDxiRtdFHkf0P9d"
    },
    "servers": [
        {
            "url": "https://api.apify.com/v2"
        }
    ],
    "paths": {
        "/acts/azureblue~fda-drug-approval-watch/run-sync-get-dataset-items": {
            "post": {
                "operationId": "run-sync-get-dataset-items-azureblue-fda-drug-approval-watch",
                "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": {
                                "$ref": "#/components/schemas/inputSchema"
                            }
                        }
                    }
                },
                "parameters": [
                    {
                        "name": "token",
                        "in": "query",
                        "required": true,
                        "schema": {
                            "type": "string"
                        },
                        "description": "Enter your Apify token here"
                    }
                ],
                "responses": {
                    "200": {
                        "description": "OK"
                    }
                }
            }
        },
        "/acts/azureblue~fda-drug-approval-watch/runs": {
            "post": {
                "operationId": "runs-sync-azureblue-fda-drug-approval-watch",
                "x-openai-isConsequential": false,
                "summary": "Executes an Actor and returns information about the initiated run in response.",
                "tags": [
                    "Run Actor"
                ],
                "requestBody": {
                    "required": true,
                    "content": {
                        "application/json": {
                            "schema": {
                                "$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": {
                                    "$ref": "#/components/schemas/runsResponseSchema"
                                }
                            }
                        }
                    }
                }
            }
        },
        "/acts/azureblue~fda-drug-approval-watch/run-sync": {
            "post": {
                "operationId": "run-sync-azureblue-fda-drug-approval-watch",
                "x-openai-isConsequential": false,
                "summary": "Executes an Actor, waits for completion, and returns the OUTPUT from Key-value store in response.",
                "tags": [
                    "Run Actor"
                ],
                "requestBody": {
                    "required": true,
                    "content": {
                        "application/json": {
                            "schema": {
                                "$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": {
                    "mode": {
                        "title": "Run mode",
                        "enum": [
                            "delta",
                            "snapshot",
                            "trial"
                        ],
                        "type": "string",
                        "description": "Delta returns only new entries since the last run. Snapshot rebuilds the full baseline. Trial returns the first 5 results with no charges — start here to evaluate. Pricing is pay-per-result ($0.02/result); there is no subscription fee.",
                        "default": "delta"
                    },
                    "sources": {
                        "title": "FDA sources to monitor",
                        "type": "array",
                        "description": "Allowed values: \"approvals\" (Drugs@FDA submissions, status AP) and \"recalls\" (openFDA drug enforcement). Pick one or both. Other strings are silently ignored.",
                        "items": {
                            "type": "string"
                        },
                        "default": [
                            "approvals",
                            "recalls"
                        ]
                    },
                    "recallClassFilter": {
                        "title": "Recall classes to include",
                        "type": "array",
                        "description": "Allowed values: \"Class I\" (high-severity), \"Class II\" (temporary/reversible), \"Class III\" (unlikely harm). Most CI buyers want Class I + II only.",
                        "items": {
                            "type": "string"
                        },
                        "default": [
                            "Class I",
                            "Class II",
                            "Class III"
                        ]
                    },
                    "webhookUrl": {
                        "title": "Webhook URL (optional)",
                        "type": "string",
                        "description": "POST endpoint that receives one JSON payload per new alert. Test with https://webhook.site to inspect payloads. Failed deliveries land in the actor's KV store under `webhook.dlq.*` for replay."
                    },
                    "webhookSecret": {
                        "title": "Webhook HMAC secret (optional)",
                        "type": "string",
                        "description": "If set, every webhook request includes `X-Azureblue-Signature: sha256=<hex>` so your endpoint can verify."
                    },
                    "maxResults": {
                        "title": "Max results per run",
                        "minimum": 1,
                        "maximum": 5000,
                        "type": "integer",
                        "description": "Cap on how many alerts the run pushes to the dataset. Default 50 — sized for a daily delta run (a typical day yields 5–30 new FDA items) and keeps per-run cost low (~$1.00 at $0.02/result). Raise it (up to 5000) for a full 90-day baseline rebuild — note that a baseline of the entire window can cost $4+ and may exceed the per-run cost cap on a low-balance account.",
                        "default": 50
                    }
                }
            },
            "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
                                    }
                                }
                            }
                        }
                    }
                }
            }
        }
    }
}
```