Track FDA untitled letters, the sub-warning-letter enforcement tier. 6,923 events indexed across drug, device, and biologics programmes.
The catalog indexes 6,923 FDA untitled letters. The untitled-letter tier sits below the warning letter: it cites a regulatory issue but does not threaten administrative action absent further failure to correct. Roughly 12% of untitled letters escalate to a warning letter within 18 months when the cited issue is not resolved. The feed below shows a recent slice including ANSM medical-device equivalents and FDA pharmaceutical promotional and postmarketing letters.
Upload suppliers, NDC codes, or device families. PharmaDB resolves to the untitled-letter taxonomy.
Every new untitled letter from FDA OPDP, FDA drug programmes, and ANSM device reviews is matched against the resolved list weekly.
Citation-anchored dossier per letter with the cited issue, the response window, and the escalation history at the same firm.
Untitled letters cite regulatory issues without threatening administrative action. The signal is corrective rather than punitive but predicts subsequent warning-letter risk.
FDA OPDP (promotional content), drug programmes (postmarketing adverse-event reporting), and device programmes all surface in one feed with the programme labelled.
Roughly 12% of untitled letters escalate to a warning letter within 18 months when the cited issue is not resolved. The escalation chip flags repeat-issue patterns at the same firm.
FDA and ANSM untitled-letter publications stream weekly. PharmaDB matches against the supplier list on each refresh.
A real chat thread in PharmaDB. Type a question, the AI agent runs the tools, the answer lands as a saveable note.
pharmagraph_query Twelve firms with two or more untitled letters in the catalog · escalation pattern shown · live warehouse.
The untitled letter monitor is the sub-warning-letter signal. PharmaDB indexes every untitled letter and computes the escalation rate to subsequent warning-letter issuance at the same firm. The view is compliance_events filtered to event_type = 'untitled_letter'. Refresh cadence is weekly.
An untitled letter is an FDA enforcement instrument that cites a regulatory issue but does not threaten administrative action. It sits below the warning letter in severity. Common subjects include promotional misbranding (FDA OPDP), postmarketing adverse-event reporting issues, and labelling deficiencies.
A warning letter cites specific violations and demands corrective action with the threat of further enforcement (import alert, seizure, injunction). An untitled letter cites a regulatory issue, requests a response, and does not threaten administrative action. The escalation path is sequential: an unresolved untitled-letter issue can become a warning letter.
Roughly 12% escalate to a warning letter within 18 months when the cited issue is not resolved. The escalation chip flags repeat-issue patterns at the same firm and powers the escalation-rate signal in the feed.
Device letters surface in the same feed because the catalog covers all FDA-regulated products. A pharmaceutical buyer can filter to drug-programme letters only; the cross-programme view is available for combination-product manufacturers.
FDA and ANSM untitled-letter publications stream weekly. PharmaDB pulls each refresh and surfaces new letters within days. Each row carries the publication date and the response-window deadline.
Yes. ANSM advisories, MHRA non-compliance notifications, and EMA inspection advisories are all tracked under the same enforcement-tier label. The cross-regulator advisory view surfaces in a combined feed at the buyer's choice.
Bring the molecule, the lane, or the supplier you're sourcing this week. The AI agent runs it on PharmaDB in 30 minutes. You keep the brief.