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FDA Drug Enforcement Monitor

by Nimblique Studio
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Regulatory IntelligenceRegulatory Intelligence

Apify-hosted software that retrieves US openFDA drug-enforcement and recall records for internal pharmaceutical quality and competitor monitoring.

FDA Drug Enforcement Monitor retrieves public US FDA drug-enforcement records and presents structured data for internal review. The current offer targets pharmaceutical quality and competitor monitoring. Its example input queries the openFDA drug-enforcement API and requests ten records sorted by report date.

The published example contains a Clindamycin Injection description, an official source link, published status and recall reason. Recall D-0815-2026 matches the FDA source record. This confirms the underlying example, but does not establish extraction accuracy across a complete Actor run. A separate supplier-hosted sample contains older device recalls and does not verify current drug-event processing.

FDA updates this enforcement source weekly. It warns against using the dataset for public alerts or tracking the recall lifecycle. Published status is not updated after classification. A frequent schedule does not make the source real time.

Adverse-event ingestion, validated safety-signal detection and case management remain unverified. The sender makes no Part 11 or GxP validation claim. The product page states that this tool is not a certification.

Key Features & Capabilities

Core Capabilities

Retrieval of US openFDA drug-enforcement and recall records from configured source URLs.
Published output fields for entity, record identifier, status, source link, recall summary and retrieval timestamp.
Input controls for output limits, per-source limits, request timeouts and retries.
Documented options to skip previously delivered logical records and preserve deduplication keys. Handling of corrected records is unverified.
Sample and live-source input modes. The current public drug example uses the live-source mode.
Scheduled recurring use is advertised on the product page.
Technical Specifications

The product runs on Apify. The current example uses an explicit openFDA drug-enforcement URL. Build 1.0.56 documents item caps, request retries and timeouts, plus state-based deduplication options. The default platform run timeout is 120 seconds; the internal overall timeout defaults to 900 seconds. Default runs select the latest build.

The output definition links to the run dataset. Apify supports JSON, CSV file, XML, Excel, HTML, RSS and JSONL dataset exports. These are platform capabilities; a complete current drug export has not been verified. Apify applies plan-dependent retention to unnamed storage and retains named storage until deletion. Product-state retention, on-premises deployment, system connectors and regional hosting commitments are unverified.

Deployment & Hosting

Cloud
Pricing Information

Reported price: US$0.02 per billed openFDA row. The pricing page shows platform usage as included. Four secondary event definitions remain configured at US$0.0001 each. The supplier needs to confirm whether the current build emits those events in addition to the primary row charge.

The metadata sets a US$0.50 minimum spending-cap option and a US$5 default run cap. The former is not evidence of a minimum fee. A per-run cap is not a monthly budget across schedules. Annual contract value, service fees, account-plan needs and any storage charges outside included run usage are unverified.

Implementation Details

The supplier provides a ten-row input example for an Apify run. A buyer must select source queries and monitoring frequency, preserve the results and review official records. Implementation timelines, training, validation services and support commitments are unverified. The latest-record query does not establish pagination or recovery of records missed between runs.

Strengths & Limitations

PharmaSpotter assessment from published vendor and third-party sources. No user reviews are on file for this product.

Strengths

Product-specific user feedback is unverified.

Limitations & Open Questions

Product-specific user feedback is unverified.

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Vendor Information
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Nimblique Studio

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