Regulatory intelligence glossary

How to use this glossary

The terms below appear throughout the site — on the recalls and shortages hubs, on record pages, and in the methodology. The definitions are written in plain language and describe each term as it is used in U.S. FDA regulatory data and on this site specifically. Where a term has a precise regulatory meaning, the definition stays close to that meaning and avoids embellishment. Where a term is one this project uses for its own derived data — such as a regulatory signal — the definition makes that origin explicit so there is no confusion between FDA terminology and this site's conventions. None of these entries is medical guidance, and several include a deliberate reminder of the boundary between an administrative classification and a clinical judgement.

FDA

The United States Food and Drug Administration, the federal agency responsible for regulating human and veterinary drugs, biologics, medical devices, food and other products in the United States. For drugs, the FDA oversees approval for marketing, post-market surveillance, recalls and the public tracking of shortages. The FDA is the authoritative source for every record indexed on this site.

openFDA

The FDA's open-data platform, which exposes many of the agency's public datasets through documented, machine-readable APIs. This site uses openFDA's Drug Enforcement and Drug Shortages endpoints as its primary sources. openFDA data is published for research and informational use and is explicitly not a substitute for the agency's official, legally controlled records.

Enforcement report

The structured record the FDA publishes for a recall action. An enforcement report captures the recall number, the recalling firm, the firm's stated reason, the product description, the distribution pattern, the classification, the status and the relevant dates. The drug recalls section of this site is built from these reports.

Recall classification

The FDA's categorisation of a recall event into one of three regulatory severity tiers — Class I, Class II or Class III. The classification expresses the agency's regulatory assessment of the recall action within its own framework. On this site it is used strictly as that administrative label and never as a personalised risk statement for any individual.

Class I recall

The most serious of the FDA's three recall classifications. It is the tier the agency applies to its highest-priority recall actions. As used here it is an administrative classification of the recall event, not a clinical judgement. See Class I recalls.

Class II recall

The intermediate of the FDA's three recall classifications, applied to a large share of routine recall actions. It is an administrative severity tier for the recall event. See Class II recalls.

Class III recall

The least serious of the FDA's three recall classifications, typically applied to recalls of a more administrative character. It is an administrative severity tier for the recall event. See Class III recalls.

Drug shortage

A period during which the supply of a drug product does not meet the demand for it, as tracked by the FDA in its public shortage data. A shortage record describes the affected product, the reporting company, the status and the relevant dates. It is a regulatory supply signal; it does not describe a product's clinical role and implies no substitution. See drug shortages.

Shortage status

The lifecycle state of a shortage record — for example current (active), resolved (ended) or discontinued. On this site these are normalised into a small, consistent vocabulary taken directly from the source data; "unknown" is used only when the source states no status.

Recalling firm

The company that initiates or conducts a recall, as named on the enforcement report. Firm names are normalised on this site so that common legal-suffix variants are collapsed, but they are never invented: a report with no identifiable firm is not attributed to a guessed company.

Distribution pattern

The enforcement-report field describing how and where a recalled product was distributed — for example, nationwide, to specific states, or to particular customer types. It is reproduced as a regulatory data field to help characterise the scope of a recall action.

Application number

The identifier the FDA assigns to a drug application (such as an NDA or ANDA) in Drugs@FDA. It ties an approved product to the application held by its sponsor. Application numbers appear in the approvals layer when that layer is populated.

Sponsor

The company that holds a drug application with the FDA — effectively the applicant or application owner. In manufacturer aggregation, sponsors from the approvals layer are treated as firms alongside recalling firms and reporting companies.

Regulatory signal

A coverage-limited, administrative indicator derived from public regulatory records — for example, how often a firm appears in the indexed recall and shortage datasets. A regulatory signal is explicitly not a quality rating, a reputational score, or a clinical judgement. See manufacturer regulatory signals.

Dataset limitation

Any known boundary on what the data can show — for example, partial field completeness, a lag between a regulatory action and its appearance in an API, a deferred layer, or a finite ingestion window. This site documents its limitations openly rather than implying completeness it does not have. See the methodology and FDA data sources pages.