{"schema":"sb.node.v1","id":"sb:e/0ad4f91ae485d31274a907f6","kind":"entity","label":{"text":"biologics evaluation","locale":"en"},"identity":{"anchor":"label:en:biologics evaluation","strength":"label"},"asOf":{"knowledgeCutoff":"2026-10-10T23:27:45.667496+00:00","snapshot":"deploy ca5d81785b2e8e9d3cb25b959dbaa72ddee4391e"},"lens":{"kind":"public"},"build":{"plane":"projected","builtFrom":["entity_graph.slim.json","entity_receipts (deploy asset)","event_graph.json","truth_records (deploy asset)","corroborated_record.json"],"rule":"node-projection.entity@v1"},"standing":{"evidence":{"supporting":32,"separatePublishers":4,"basis":"documents that mention the subject and the outlets that carried them; a mention is evidence the referent is in use, not evidence about any claim","receiptsOnTopic":{"state":"partial","share":0.125,"named":4,"of":32,"basis":"documents whose own title or summary lead names the subject, over every counted document that mentions it anywhere (the entity graph's measurement); receipts are drawn from the former only","blind":["only 13% of the 32 documents measured name the subject in their own text; the rest mention it in passing, so standing.evidence.supporting overstates coverage about it"]}},"admission":{"state":"provisional","reason":"entity graph provenance 'observed'; the node carries no promotion receipt in v1","policy":"EQ-PROMOTION (receipt not carried)"},"disposition":{"state":"served","reason":"public record"},"validity":{"from":"2026-04-14","to":"2026-10-09","basis":"first and last day we saw it mentioned; not the subject's own lifetime"},"measurement":{"state":"partial","blind":["assertion coverage 0.562: about 44% of mentions carry no typed assertion"]}},"dimensions":{"domains":["biotech_pharma","pharma-regulatory"],"activeDays":17,"assertions":{"regulatory-approval":17,"award":1}},"up":[],"upNote":"An entity is a root: it is contained by nothing. Pan out by following R.","children":{"count":4,"byKind":{"observation":4},"items":[{"id":"sb:o/b1b1112392a0cf62fedb2f85","kind":"observation","label":"FDA Drug News · 2026-06-13 · [APPROVAL] Real-World Evidence Submissions to the Center for Biologics Evaluation and Research & the Center for Drug Evaluation and Research","url":"http://www.fda.gov/science-research/real-world-evidence/real-world-evidence-submissions-center-biologics-evaluation-and-research-center-drug-evaluation-and"},{"id":"sb:o/8241e1c92f5efc9a3afb0635","kind":"observation","label":"FDA · 2026-10-09 · Questions and Answers on Biosimilar Development and the BPCI Act","url":"http://www.fda.gov/regulatory-information/search-fda-guidance-documents/questions-and-answers-biosimilar-development-and-bpci-act"},{"id":"sb:o/abdc13ee553c467883e34d0d","kind":"observation","label":"FDA · 2026-09-30 · Study Data Standards Resources","url":"http://www.fda.gov/industry/fda-data-standards-advisory-board/study-data-standards-resources"},{"id":"sb:o/8c27e5ade7cc2087ae942317","kind":"observation","label":"FDA · 2026-09-10 · FDA-TRACK: Expanded Access (Compassionate Use) Submission Data","url":"http://www.fda.gov/about-fda/fda-track-agency-wide-program-performance/fda-track-expanded-access-compassionate-use-submission-data"}],"cursor":null,"order":"newest first; we keep the 4 newest receipts for this entity whose own title or summary lead (the entity graph's test) names it. Its other observations are counted in standing.evidence.supporting but are not addressable in v1"},"relations":{"count":10,"byKind":{"co-mentioned":10},"items":[{"kind":"relation","label":"co-mentioned with fda (32 documents)","role":"co-mentioned","relationKind":"co-mentioned","members":2,"id":"sb:r/ce557acd8c3a7367e54388fa"},{"kind":"relation","label":"co-mentioned with drug evaluation (26 documents)","role":"co-mentioned","relationKind":"co-mentioned","members":2,"id":"sb:r/3c1e009098377e6278261ca6"},{"kind":"relation","label":"co-mentioned with cber (20 documents)","role":"co-mentioned","relationKind":"co-mentioned","members":2,"id":"sb:r/261af4582d9f31af36da8937"},{"kind":"relation","label":"co-mentioned with cder (18 documents)","role":"co-mentioned","relationKind":"co-mentioned","members":2,"id":"sb:r/6bbf13f97c1f6910cb50b60a"},{"kind":"relation","label":"co-mentioned with drug administration (18 documents)","role":"co-mentioned","relationKind":"co-mentioned","members":2,"id":"sb:r/d8448703bfd374832e52470f"},{"kind":"relation","label":"co-mentioned with biological products (10 documents)","role":"co-mentioned","relationKind":"co-mentioned","members":2,"id":"sb:r/9d3f2a0637d559e73a886301"},{"kind":"relation","label":"co-mentioned with u.s. food (10 documents)","role":"co-mentioned","relationKind":"co-mentioned","members":2,"id":"sb:r/3426138f98d5a94922f34f4c"},{"kind":"relation","label":"co-mentioned with investigational new drug (9 documents)","role":"co-mentioned","relationKind":"co-mentioned","members":2,"id":"sb:r/c0fa90f6ffd2cabeec8a7ba5"},{"kind":"relation","label":"co-mentioned with drug development (8 documents)","role":"co-mentioned","relationKind":"co-mentioned","members":2,"id":"sb:r/6a2a22526e479328375ce826"},{"kind":"relation","label":"co-mentioned with radiological health (8 documents)","role":"co-mentioned","relationKind":"co-mentioned","members":2,"id":"sb:r/14d7205c3ebe7b4b819ceb70"}],"cursor":null,"order":"situations first, then claims (the subject's own maintained record, then site-wide corroborated clusters; each label ends with its standing), then co-mentions by shared documents, descending. Co-mentions are the ten strongest the entity graph keeps per entity"},"edge":{"state":"continues"},"links":{"rest":"/api/v1/node/e/0ad4f91ae485d31274a907f6","mcp":"traverse {\"id\":\"sb:e/0ad4f91ae485d31274a907f6\"}","page":"/entity/biologics-evaluation/"},"limits":{"levelsPerCall":1,"pageSize":10,"maxPageSize":50,"membersMax":50,"statement":"One level per call: depth is 1 and only 1, and there is no whole-graph dump. pageSize 1-50 (default 10); a page limit is a cursor, never an edge. Members are listed up to 50. At most 60 traverse calls a minute per caller (runaway-loop protection, not a meter). One knowledge cutoff is served: the deploy's."},"actions":[{"verb":"unfold","lit":true,"effect":"read","layer":"cantina","call":"traverse {\"id\":\"sb:e/0ad4f91ae485d31274a907f6\",\"level\":\"children\"}"},{"verb":"fold","lit":true,"effect":"read","layer":"cantina","call":"traverse {\"id\":\"sb:e/0ad4f91ae485d31274a907f6\"}"},{"verb":"panOut","lit":false,"effect":"read","layer":"cantina","reason":"An entity is a root: it is contained by nothing. Pan out by following R."},{"verb":"follow","lit":true,"effect":"read","layer":"cantina","call":"traverse {\"id\":\"sb:e/0ad4f91ae485d31274a907f6\",\"level\":\"relations\"}"},{"verb":"receipts","lit":false,"effect":"read","layer":"cantina","reason":"receipts are the observations below this node; unfold to reach them"},{"verb":"edge","lit":true,"effect":"read","layer":"cantina","call":"traverse {\"id\":\"sb:e/0ad4f91ae485d31274a907f6\"}"},{"verb":"asOf","lit":false,"effect":"read","layer":"cantina","reason":"v1 serves one knowledge cutoff, this deploy's; walking an earlier cutoff needs retained history (EQ-REPLAY), which v1 does not keep"},{"verb":"switchObserver","lit":false,"effect":"read","layer":"cantina","reason":"the public record is the same for every observer; traversal through a Watch's lens is not served in v1"},{"verb":"readOriginal","lit":false,"effect":"read","layer":"cantina","reason":"no translation is applied on this node; every label is the source's own text"},{"verb":"save","lit":false,"effect":"watch-declaration","layer":"workshop","reason":"saving applies to a configured Watch; configure one around this node first (free), then save it"},{"verb":"deliver","lit":false,"effect":"watch-declaration","layer":"workshop","reason":"delivery applies to a saved Watch"},{"verb":"format","lit":false,"effect":"watch-declaration","layer":"workshop","reason":"output format applies to a saved Watch"},{"verb":"deltaR","lit":false,"effect":"read","layer":"workshop","reason":"Delta R needs a saved Watch with a previous reading"},{"verb":"read","lit":false,"effect":"read","layer":"docking-bay","reason":"one-time Reads are parked until the Commander decides their shape (#938)"}]}