{"id":"W4366252127","doi":"10.1007/s43441-023-00522-4","title":"Comparative Expedited Regulatory Programs of U.S Food &amp; Drug Administration and Project Orbis Partners","year":2023,"lang":"en","type":"review","venue":"Therapeutic Innovation & Regulatory Science","topic":"Health Systems, Economic Evaluations, Quality of Life","field":"Economics, Econometrics and Finance","cited_by":8,"is_retracted":false,"has_abstract":false,"ca_institutions":"Health Canada","funders":"","keywords":"Medicine; Regulatory science; Agency (philosophy); Health care; Pharmacy; Food and drug administration; Marketing authorization; Excellence; Orphan drug; Family medicine; Business; Political science; Pharmacology; Bioinformatics","routes":{"ca_aff":true,"ca_fund":false,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.009547645,0.0006283062,0.000922134,0.004015076,0.0004577942,0.001788152,0.001161007,0.001473566,0.01805347],"category_scores_gemma":[0.009592513,0.0002425316,0.001074134,0.003956386,0.0004742461,0.001262179,0.001068928,0.001766072,0.002445902],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.003108026,"about_ca_system_score_gemma":0.01655596,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.01117657,"about_ca_topic_score_gemma":0.02123898,"domain_scores_codex":[0.9971905,0.001022968,0.0002532586,0.0002161959,0.00111563,0.0002015129],"domain_scores_gemma":[0.993636,0.0026864,0.000810934,0.0002666601,0.002364183,0.0002358833],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"not_applicable","study_design_scores_codex":[0.0002744316,0.00008797919,0.000335219,0.01380968,0.0001687923,0.00004124343,0.0000300298,0.0002525879,0.0003284385,0.01957161,0.1150865,0.8500136],"study_design_scores_gemma":[0.0001495503,0.0001146284,0.002625003,0.01303835,0.0002733703,0.0001339216,0.00003648017,0.00005465851,0.000569211,0.001500897,0.98149,0.00001396391],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.0005256786,0.9736953,0.0004359481,0.004426258,0.0005735952,0.0001260589,0.0008480248,0.00004625976,0.01932283],"genre_scores_gemma":[0.01001569,0.9761637,0.001775332,0.002636638,0.0002841382,0.0002585176,0.001181353,0.00002519343,0.00765946],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.01805347,"threshold_uncertainty_score":0.06039488,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.7146501137971667,"score_gpt":0.5414654716872503,"score_spread":0.1731846421099164,"validation_status":"score_only:v0-immature-baseline","note":"Baseline scores from an immature model (maturity gate not passed). Scores rank; they never assert a category."}}