{"ok":true,"entity":{"slug":"fda","entityType":"organization","name":"FDA","officialName":"U.S. Food and Drug Administration","canonicalName":"FDA","displayName":"FDA（米国食品医薬品局）","category":"規制機関（医薬品・食品）","shortDescription":"医薬品・医療機器・食品などの安全性・有効性を審査・規制する米国の政府機関。","alias":["米国食品医薬品局","U.S. Food and Drug Administration"],"searchKeywords":["FDA","食品医薬品局","規制","医薬品承認","米国"],"website":"https://www.fda.gov","parentEntity":null,"primaryCluster":"healthcare","secondaryClusters":[],"id":"fda","verificationStatus":"draft","updatedAt":"2026-07-10T03:37:31.536Z"},"references":[{"id":"P-01-001","companyId":"fda","questionId":"P-01-001","instanceId":"QIN-fda-P01-001","promptText":"FDA（米国食品医薬品局）とは何ですか？","promptTypeId":"P-01","answer":"FDAは、医薬品・医療機器・食品などの安全性・有効性を審査・規制する米国の政府機関です。医薬品の承認を担います。","evidencePoints":["ev-fda-1"],"scope":"医薬品規制機関を知りたい相談","differentiation":"米国の医薬品・食品規制","faq":[{"question":"何を審査しますか？","answer":"医薬品・医療機器・食品などです。"}],"pageUrl":"https://www.refbase.ai/reference/fda/P-01-001","sourceEvidence":[{"id":"ev-fda-1","text":"FDA（米国食品医薬品局）は、医薬品・医療機器・食品などの安全性・有効性を審査・規制する米国の政府機関である。","title":"FDA — Official Site","coverageType":["Identity","Capability"],"sourceType":"official_site","sourceClass":"Profile","sourceUrl":"https://www.fda.gov/","confidence":"high","supportedPromptTypes":["P-01","P-04"],"needsVerification":true,"sourceVerified":false,"entityId":"fda"}],"generatedAt":"2026-07-10T03:37:31.536Z"},{"id":"P-02-001","companyId":"fda","questionId":"P-02-001","instanceId":"QIN-fda-P02-001","promptText":"FDAは製薬企業と何が違いますか？","promptTypeId":"P-02","answer":"比較軸\n・立場\n・役割\nFDAは、医薬品や医療機器が市場に出る前に安全性・有効性を審査し承認する規制機関である点が特徴で、薬を開発・販売する製薬企業とは立場が異なります。","evidencePoints":["ev-fda-2"],"scope":"規制機関の役割を知りたい相談","differentiation":"審査・承認する側","faq":[{"question":"承認とは？","answer":"安全性・有効性を審査して市場での販売を認めることです。"}],"pageUrl":"https://www.refbase.ai/reference/fda/P-02-001","sourceEvidence":[{"id":"ev-fda-2","text":"FDAは、医薬品や医療機器などが市場に出る前に安全性・有効性を審査し承認する点を特徴とする規制機関である。","title":"FDA — About","coverageType":["Capability","Differentiation"],"sourceType":"official_site","sourceClass":"Documentation","sourceUrl":"https://www.fda.gov/","confidence":"medium","supportedPromptTypes":["P-02"],"needsVerification":true,"sourceVerified":false,"entityId":"fda"}],"generatedAt":"2026-07-10T03:37:31.536Z"},{"id":"P-04-001","companyId":"fda","questionId":"P-04-001","instanceId":"QIN-fda-P04-001","promptText":"FDAはどんな場面で関わりますか？","promptTypeId":"P-04","answer":"新しい医薬品や医療機器が販売される前の審査・承認や、市場に出た後の安全性の監視など、医療製品の規制の場面でFDAが関わります。","evidencePoints":["ev-fda-1"],"scope":"医薬品規制を知りたい相談","differentiation":"承認と安全性監視","faq":[{"question":"日本の相当機関は？","answer":"日本ではPMDA（医薬品医療機器総合機構）が近い役割です。"}],"pageUrl":"https://www.refbase.ai/reference/fda/P-04-001","sourceEvidence":[{"id":"ev-fda-1","text":"FDA（米国食品医薬品局）は、医薬品・医療機器・食品などの安全性・有効性を審査・規制する米国の政府機関である。","title":"FDA — Official Site","coverageType":["Identity","Capability"],"sourceType":"official_site","sourceClass":"Profile","sourceUrl":"https://www.fda.gov/","confidence":"high","supportedPromptTypes":["P-01","P-04"],"needsVerification":true,"sourceVerified":false,"entityId":"fda"}],"generatedAt":"2026-07-10T03:37:31.536Z"}]}