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Pan out by following R.","children":{"count":8,"byKind":{"observation":8},"withheld":{"state":"withheld","count":4,"reason":"4 receipts withheld: no source link (the same rule the topic record applies)"},"items":[{"id":"sb:o/22521211dd5e108ace35426c","kind":"observation","label":"FDA · 2026-11-08 · PDUFA and BsUFA Quarterly Hiring Updates","url":"http://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-and-bsufa-quarterly-hiring-updates","match":{"surface":"title","basis":"admitted by the entity graph's subject gate (title or URL); the headline names the subject as whole words (the door's on-topic test)"}},{"id":"sb:o/f83dbecd4dfea7b03814094e","kind":"observation","label":"GEN · 2026-11-02 · FDA Sets May 1 PDUFA Action Date for uniQure’s Huntington’s Disease Gene Therapy","url":"https://www.genengnews.com/topics/genome-editing/fda-sets-may-1-pdufa-action-date-for-uniqures-huntingtons-disease-gene-therapy/","match":{"surface":"title","basis":"admitted by the entity graph's subject gate (title or URL); the headline names the subject as whole words (the door's on-topic test)"}},{"id":"sb:o/0bb450f207108a3b9ff0433e","kind":"observation","label":"GEN · 2026-11-02 · FDA Delays PDUFA Action on Agios’ Mitapivat sNDA for SCD","url":"https://www.genengnews.com/topics/translational-medicine/fda-delays-pdufa-action-on-agios-mitapivat-snda-for-scd/","match":{"surface":"title","basis":"admitted by the entity graph's subject gate (title or URL); the headline names the subject as whole words (the door's on-topic test)"}},{"id":"sb:o/2135178450fd1a9f3ae0b004","kind":"observation","label":"Endpoints News · 2026-10-30 · Gilead CAR-T on partial clinical hold; Agios' PDUFA date pushed back","url":"https://endpoints.news/gilead-car-t-on-partial-clinical-hold-agios-pdufa-date-pushed-back/","match":{"surface":"title","basis":"admitted by the entity graph's subject gate (title or URL); the headline names the subject as whole words (the door's on-topic test)"}},{"id":"sb:o/2848fefe44d43c51fff40a12","kind":"observation","label":"U.S. Chamber of Commerce · 2026-10-15 · U.S. Chamber Comments on FDA's PDUFA VIII Reauthorization Process","url":"https://www.uschamber.com/health-care/u-s-chamber-comments-on-fdas-pdufa-viii-reauthorization-process","match":{"surface":"title","basis":"admitted by the entity graph's subject gate (title or URL); the headline names the subject as whole words (the door's on-topic test)"}},{"id":"sb:o/cbfd03568eca5ed29af2f23d","kind":"observation","label":"Endpoints News · 2026-10-08 · New PDUFA deal sets aside FDA money to rehire reviewers","url":"https://endpoints.news/new-pdufa-deal-sets-aside-fda-money-to-rehire-reviewers-lost-to-layoffs/","match":{"surface":"title","basis":"admitted by the entity graph's subject gate (title or URL); the headline names the subject as whole words (the door's on-topic test)"}},{"id":"sb:o/ecbfa9d16956934058d721c6","kind":"observation","label":"FDA Drug News · 2026-08-25 · PDUFA VII Information Technology and Bioinformatics Goals and Progress","url":"http://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-information-technology-and-bioinformatics-goals-and-progress","match":{"surface":"title","basis":"admitted by the entity graph's subject gate (title or URL); the headline names the subject as whole words (the door's on-topic test)"}},{"id":"sb:o/5488eac888dd0483eb1a8f8b","kind":"observation","label":"FDA Drug News · 2026-08-20 · [APPROVAL] Completed PDUFA VII Deliverables","url":"http://www.fda.gov/industry/prescription-drug-user-fee-amendments/completed-pdufa-vii-deliverables","match":{"surface":"title","basis":"admitted by the entity graph's subject gate (title or URL); the headline names the subject as whole words (the door's on-topic test)"}}],"cursor":null,"order":"newest first; we keep the 8 newest receipts for this entity whose own title or URL (the entity graph's subject gate) names it; each says which in match. 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 (53 documents)","role":"co-mentioned","relationKind":"co-mentioned","members":2,"id":"sb:r/cab8d6b83b0423f564107b13"},{"kind":"relation","label":"co-mentioned with cder (22 documents)","role":"co-mentioned","relationKind":"co-mentioned","members":2,"id":"sb:r/393b3bf4db2fd34e8c1e750a"},{"kind":"relation","label":"co-mentioned with clinical trial (20 documents)","role":"co-mentioned","relationKind":"co-mentioned","members":2,"id":"sb:r/42f672d41fcc1163372c3996"},{"kind":"relation","label":"co-mentioned with prescription drug user (19 documents)","role":"co-mentioned","relationKind":"co-mentioned","members":2,"id":"sb:r/af8994fa41110df2b856880f"},{"kind":"relation","label":"co-mentioned with clinical trials (17 documents)","role":"co-mentioned","relationKind":"co-mentioned","members":2,"id":"sb:r/388a02c18e0188be9cf973c1"},{"kind":"relation","label":"co-mentioned with fee act (17 documents)","role":"co-mentioned","relationKind":"co-mentioned","members":2,"id":"sb:r/e58f0baa402f585f7e7e2631"},{"kind":"relation","label":"co-mentioned with draft guidance (15 documents)","role":"co-mentioned","relationKind":"co-mentioned","members":2,"id":"sb:r/1049f950955e00c91084bc0b"},{"kind":"relation","label":"co-mentioned with drug evaluation (15 documents)","role":"co-mentioned","relationKind":"co-mentioned","members":2,"id":"sb:r/8ac4b640ced2a7be13456f12"},{"kind":"relation","label":"co-mentioned with drug administration (13 documents)","role":"co-mentioned","relationKind":"co-mentioned","members":2,"id":"sb:r/def0a3547e7ff3f3c5e3f070"},{"kind":"relation","label":"co-mentioned with priority review (13 documents)","role":"co-mentioned","relationKind":"co-mentioned","members":2,"id":"sb:r/043c0ae6f01a8b5053803d34"}],"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/af4acddc2079ea55a285bdbf","mcp":"traverse {\"id\":\"sb:e/af4acddc2079ea55a285bdbf\"}","page":"/entity/pdufa/"},"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":"free-record","call":"traverse {\"id\":\"sb:e/af4acddc2079ea55a285bdbf\",\"level\":\"children\"}"},{"verb":"fold","lit":true,"effect":"read","layer":"free-record","call":"traverse {\"id\":\"sb:e/af4acddc2079ea55a285bdbf\"}"},{"verb":"panOut","lit":false,"effect":"read","layer":"free-record","reason":"An entity is a root: it is contained by nothing. Pan out by following R."},{"verb":"follow","lit":true,"effect":"read","layer":"free-record","call":"traverse {\"id\":\"sb:e/af4acddc2079ea55a285bdbf\",\"level\":\"relations\"}"},{"verb":"receipts","lit":false,"effect":"read","layer":"free-record","reason":"receipts are the observations below this node; unfold to reach them"},{"verb":"edge","lit":true,"effect":"read","layer":"free-record","call":"traverse {\"id\":\"sb:e/af4acddc2079ea55a285bdbf\"}"},{"verb":"asOf","lit":false,"effect":"read","layer":"free-record","reason":"v1 serves one knowledge cutoff, this deploy's; walking an earlier cutoff needs retained history, which v1 does not keep"},{"verb":"switchObserver","lit":false,"effect":"read","layer":"free-record","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":"free-record","reason":"no translation is applied on this node; every label is the source's own text"},{"verb":"save","lit":false,"effect":"watch-declaration","layer":"watch","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":"watch","reason":"delivery applies to a saved Watch"},{"verb":"format","lit":false,"effect":"watch-declaration","layer":"watch","reason":"output format applies to a saved Watch"},{"verb":"deltaR","lit":false,"effect":"read","layer":"watch","reason":"Delta R needs a saved Watch with a previous reading"},{"verb":"read","lit":false,"effect":"read","layer":"one-time-read","reason":"one-time Reads are not offered through this door; use ask"}]}