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.

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: 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.
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 is built around companies that received one.
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.
Corpus: A set of records from one source that the Ephemeris charts: the FDA corpus and the SEC corpus.
Decision: On the Alzheimer's record, one FDA action on an anti-amyloid antibody: an approval or a complete response letter.
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.
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.
Federal Register: The U.S. government's daily journal of notices, including FDA advisory committee meeting announcements.
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.
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.
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.
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.