Openfda

Quality – / 100not scored

Not scored: fewer than three checks apply, usually because no remote answered a credential-free probe or the server is a local package.

Tool list unknown · tools last changed 2026-10-18 · checked 2026-10-20 10:03 UTC

Tool changes

• 2026-10-18fda_postmarket_risk_profileremoved

  Combine a drug’s FAERS reporting profile, label warning fields, and FDA recall records for review routing. This is not a validated safety comparison, causal assessment, incidence estimate, or substitute for FDA communications and clinical review.

• 2026-10-18fda_application_historyremoved

  Retrieve one Drugs@FDA NDA, ANDA, or BLA application and return its products and chronological submission-action history. Submission codes require regulatory interpretation and do not by themselves establish approval scope, exclusivity, or current marketing.

• 2026-10-18fda_faers_trendremoved

  Aggregate daily FAERS report counts into calendar months for a drug and optional reaction over a bounded date window. The reaction argument matches one whole MedDRA preferred term, so a broad word like "neuropathy" counts only reports filed under that exact term and not the specific terms containing it. Natural multi-word phrasing is resolved to MedDRA word order and disclosed; a term matching nothing is reported as unresolved rather than as zero reports. Trends reflect reporting activity, publicity, utilization, duplicates, and database updates—not incidence or changing clinical risk.

• 2026-10-18fda_faers_reaction_profileremoved

  Summarize the most frequently co-reported FAERS reactions plus serious/non-serious report counts for a drug. Counts are spontaneous reports with duplicates, co-medications, and reporting bias—not event rates or proof of causation.

• 2026-10-18fda_faers_signal_summaryremoved

  Calculate report-level FAERS disproportionality routing metrics for one drug/reaction pair using a 2×2 reporting table. The reaction argument matches one whole MedDRA preferred term, so a broad word like "neuropathy" counts only reports filed under that exact term and not the specific terms containing it. Natural multi-word phrasing is resolved to MedDRA word order and disclosed; a term matching nothing is reported as unresolved rather than as zero reports. ROR/PRR are screening statistics—not incidence, causality, comparative drug safety, or an FDA safety conclusion.

• 2026-10-18fda_warning_lettersremoved

  Search FDA WARNING LETTERS — official enforcement letters FDA sends firms for violations (CGMP, adulterated/misbranded products, unapproved claims). Answers "has <company> received an FDA warning letter", "recent FDA warning letters about supplements/devices". By default `search` matches the RECIPIENT company the letter was issued to, so the answer is about that firm's own enforcement history; set match:"fulltext" to search the whole letter record instead, which also finds letters that merely mention a firm. Every row reports matched_field so a caller can tell "issued to" from "mentions". Covers the 3,680 letters fda.gov publishes from 2021 onward — recipient company, posted and issued dates, issuing FDA office, subject and a link to the full letter text — and, for a firm with nothing in that window, falls back to the FDA compliance-actions archive of older letters back to 2010, which gives the firm, place, product type and issue date but no document. Every row says which of the two it came from. Live, no caller credential needed.

• 2026-10-18fda_event_countsremoved

  Aggregate adverse events by reaction type, patient age, or outcome. Returns top reactions for a drug and event trends over time.

• 2026-10-18fda_food_recallsremoved

  Search FDA FOOD recall / enforcement reports (openFDA /food/enforcement) — product recalls, reasons, classification, recalling firm, distribution, and status. Use for food-safety / recall-history questions (distinct from fda_drug_recalls which covers drugs).

• 2026-10-18fda_crl_detailremoved

  Retrieve one FDA Complete Response Letter by application number and optionally letter date. Returns the FDA-disclosed letter text and document URL. Confidential commercial and trade-secret material may be redacted by FDA.

• 2026-10-18fda_complete_response_lettersremoved

  Search FDA-disclosed Complete Response Letters for drug and biologic applications. Defaults to letter_type "COMPLETE RESPONSE"; optionally include other letter types in the same dataset. Returns the application’s current approval_status, letter metadata, an excerpt, and the official document URL.

Showing the latest 10. Full history: list_changes · trend: quality JSON.

Checks run on what our credential-free, read-only probes observe; tools are never called and no code audit is performed. How it is computed.