Pricing

from $10.00 / 1,000 approval returneds

openFDA Approvals Monitor

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.

Pricing

from $10.00 / 1,000 approval returneds

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Developer

ByteHaven Studios

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Monthly active users

2 days ago

Last modified

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Approval streams

endpoints

Optional

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).

Type:string[]

Applicants / sponsors to watch

applicants

Optional

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).

Type:array

Device product codes to watch

productCodes

Optional

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.

Type:array

Approved on/after (YYYY-MM-DD)

approvedSince

Optional

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).

Type:string

Example:2026-07-01

Approved on/before (optional upper bound, YYYY-MM-DD)

approvedUntil

Optional

Optional upper bound on the approval/decision date. Leave empty for no upper bound (up to today).

Type:string

Example:2026-07-10

Only new since last run

monitorNewOnly

Optional

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.

Type:boolean

Default:false

Fields to keep

fields

Optional

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).

Type:array

Max approvals per run

maxResults

Optional

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).

Type:integer

Minimum:0

Default:0

openFDA API key (optional)

apiKey

Optional

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/.

Type:string

Proxy configuration

proxyConfiguration

Optional

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.

Type:object

Default:

{
  "useApifyProxy": false
}

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