Glossary

Plain definitions of the regulatory and site terms used across EphemerisX sites.

Terms are listed alphabetically. Regulatory terms are described as they are used on EphemerisX sites; for legal definitions, see the FDA's own glossaries. For longer, plain-language explanations with the FDA's and the SEC's own definitions, see FDA approval terms, Cancer trial terms and SEC filing terms.

Accelerated approval: An FDA approval based on a surrogate endpoint that is reasonably likely to predict clinical benefit. It usually requires a confirmatory trial afterwards. Compare traditional approval.
Action date: The date on the FDA's action letter: the day it approved an application or issued a complete response letter.
Advisory committee: A panel of outside experts the FDA may ask to discuss an application and vote on questions. Its vote is advice; the FDA decides.
Anti-amyloid antibody: A drug class that targets amyloid beta in the brain: Aduhelm (aducanumab), Leqembi and Leqembi Iqlik (lecanemab) and Kisunla (donanemab).
Application (NDA, BLA): The sponsor's request to market a drug. A New Drug Application (NDA) covers most drugs; a Biologics License Application (BLA) covers biologics such as antibodies. Each has a number, for example BLA 761269, which links to Drugs@FDA on EphemerisX sites.
ARIA: Amyloid-related imaging abnormalities: brain swelling (ARIA-E, for edema) or small bleeds (ARIA-H, for hemosiderin) seen on MRI. A central safety question for anti-amyloid antibodies, and thread T3 on the Alzheimer's record.
Case: In deep research, a question web built around one FDA decision, read alongside other companies' filings about it, up to the next open decision. See Cases. On the Ephemeris, an FDA decision read from the documents. Listed under Cases in the record. The same decisions have entries on the Alzheimer's record.
Citation: The source line under a quote: document, PDF page, action date and a link to fda.gov. See Reading the record.
Class 1 resubmission: A resubmission after a Complete Response Letter that the FDA classes as addressing minor matters, with a two-month review goal; a Class 2 resubmission has six months. See FDA approval terms.
Complete Response Letter (CRL): The FDA's letter saying it will not approve an application in its present form, and why. Shown as Refused on the Alzheimer's record. The SEC Ephemeris and deep research are built around companies that received one. See FDA approval terms.
Concept preview: A working demonstration of a product that is not yet available. Ask the Ephemeris is a concept preview: its questions were answered and checked in advance.
Confirmatory trial: A study the FDA requires after an accelerated approval to confirm the clinical benefit. Often set as a postmarketing requirement (PMR). Thread T5 on the Alzheimer's record.
Connection: On a question web, a line between two questions whose answers quote the same passage, or rely on the same search. See What a connection means.
Corpus: A set of records from one source that the Ephemeris charts: the FDA corpus and the SEC corpus.
Cross-investigation: A deep research question answered across several companies' records, through a specific shared point of evidence. See Connections across cases.
Decision: On the Alzheimer's record, one FDA action on an anti-amyloid antibody: an approval or a complete response letter.
Deep research: Answers to questions that sit between public records, such as an FDA letter and the company's SEC filings, built from verified passages. See Deep research overview.
Drugs@FDA: The FDA's public database of approved drugs, their applications, labels and review documents.
Entity: A dot on the Ephemeris: a named thing found in the documents, such as a trial, endpoint, dose, adverse event or organisation.
Finding: One piece of evidence in a deep research answer: a passage found word for word in a named document, or a whole-document search that found nothing. The concept preview counts them on every answer.
8-K and 10-K: SEC filings. An 8-K (current report) announces a material event, such as receiving a CRL; its exhibit 99 is often a press release. A 10-K is the annual report. See SEC filing terms.
Federal Register: The U.S. government's daily journal of notices, including FDA advisory committee meeting announcements.
Formal dispute resolution: The FDA process through which a sponsor appeals a decision, such as a Complete Response Letter, above the review division that made it.
Graph behind: An Ephemeris status: the item's graph exists, but newer documents arrived after it was built.
In the graph / In the system: On the Ephemeris, a document is in the system once EphemerisX holds it, and in the graph once it has been read into the knowledge graph.
Label (Prescribing Information): The FDA-approved document that tells prescribers what a drug is for, how to dose it and its risks. Indications, boxed warnings and dosing on EphemerisX sites are quoted from it.
Listed only: An Ephemeris status: the approval is known from Drugs@FDA, but its documents have not been fetched.
NCT number: A trial's registration number on ClinicalTrials.gov, for example NCT04437511.
“Not in” statement: A statement that a document does not mention something, backed by a search of the whole document for named terms. See “Not in” statements.
OCR: Optical character recognition: reading text from an image of a page. Quotes from scanned pages are marked.
PDF page: The page number your PDF viewer counts, starting at 1 on the first page of the file. Citations use it.
Position: On the Alzheimer's record, the agency's own words on one thread in one decision, with a status comparing it to an earlier position.
Projected: On the Ephemeris, a translucent placeholder for what a queued document is expected to add. Not real data until the package is built.
Queued: An Ephemeris status: the documents are in the system, waiting to be read into the graph.
Question web: One company's regulatory history after an FDA letter, as a set of answered questions joined by connections. See Question webs.
Reasoning graph: In the concept preview, the findings beneath an answer, arranged in the order the argument runs. Click a node to see its passage. See Reasoning and evidence.
Relation: A line on the Ephemeris between two entities that the documents connect.
Response path: On the SEC Ephemeris, what a company did after its CRL, for example Response in progress or Resubmitted; CRL again.
sha256: A 64-character fingerprint of a file. Two files with the same sha256 are identical. See Verify a document.
Shared concepts: On the Ephemeris, one dot for a concept every drug refers to, such as Alzheimer's disease, linked to each drug that mentions it.
Sponsor: The company that holds the application.
Surrogate endpoint: A measure, such as amyloid on a PET scan, used in place of a direct measure of how patients feel or function. Thread T1 on the Alzheimer's record.
Thread: On the Alzheimer's record, one of five regulatory questions followed across every decision: Surrogate, Effect size, ARIA, Data and Confirmatory.
Type A meeting: A formal meeting the FDA holds when a development programme is stalled or there is an important safety issue; companies often request one after a Complete Response Letter. See FDA approval terms.
Traditional approval: An FDA approval based on direct evidence of clinical benefit. An accelerated approval can later be converted to one.
Up to date: An Ephemeris status: every document in the system for the item is in the graph.