{"id":"W4392778751","doi":"10.1017/jme.2024.20","title":"Aducanumab, Accelerated Approvals &amp; the Agency: Why the FDA Needs Structural Reform","year":2023,"lang":"en","type":"article","venue":"The Journal of Law Medicine & Ethics","topic":"Pharmaceutical Economics and Policy","field":"Economics, Econometrics and Finance","cited_by":4,"is_retracted":false,"has_abstract":true,"ca_institutions":"Dalhousie University","funders":"Canadian Institutes of Health Research","keywords":"Agency (philosophy); Food and drug administration; Hard core; Drug approval; Public administration; Political science; Business; Drug; Medicine; Pharmacology; Sociology; Risk analysis (engineering)","routes":{"ca_aff":true,"ca_fund":true,"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":[0.02637525,0.0002862975,0.0005958825,0.001069182,0.006988114,0.01250909,0.001390945,0.0202507,0.00657022],"category_scores_gemma":[0.05516768,0.0004644153,0.0008815121,0.001175373,0.01981364,0.01478976,0.003945502,0.01959928,0.001153973],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.01276837,"about_ca_system_score_gemma":0.0191546,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.01628739,"about_ca_topic_score_gemma":0.01272209,"domain_scores_codex":[0.9823778,0.009107851,0.0006098372,0.001538314,0.003517035,0.002849215],"domain_scores_gemma":[0.9512063,0.03539916,0.003349873,0.002179941,0.005174312,0.002690502],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"theoretical_or_conceptual","study_design_gemma":"not_applicable","study_design_scores_codex":[0.00005090941,0.00004719302,0.0009215489,0.00006739078,0.000009205988,0.0001914437,0.0009002961,0.0003384852,0.000382118,0.9399015,0.04577125,0.01141855],"study_design_scores_gemma":[0.0002837323,0.0001408752,0.00343187,0.0005042336,0.00003995843,0.0003941469,0.002362069,0.001816498,0.00127607,0.6188601,0.3708088,0.00008155874],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"commentary","genre_gemma":"commentary","genre_scores_codex":[0.01302628,0.003137055,0.002614836,0.9569385,0.0004656004,0.00003266879,0.00003726227,0.0000277893,0.02372],"genre_scores_gemma":[0.5929298,0.004711275,0.005709237,0.3810826,0.002879871,0.0001817028,0.00004648818,0.00007842557,0.01238051],"genre_candidate":"commentary","genre_consensus":"commentary","teacher_disagreement_score":0.02637525,"threshold_uncertainty_score":0.1394873,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.3608648809949944,"score_gpt":0.4087868544371139,"score_spread":0.04792197344211946,"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."}}