{"id":"W4415782015","doi":"10.1007/978-981-95-1920-0_24","title":"Regulation of Healthcare Products by the United States Food and Drug Administration and Health Canada","year":2025,"lang":"en","type":"book-chapter","venue":"Introduction to Basics of Pharmacology and Toxicology","topic":"Biomedical Ethics and Regulation","field":"Medicine","cited_by":0,"is_retracted":false,"has_abstract":false,"ca_institutions":"","funders":"","keywords":"Food and drug administration; Medical prescription; Health care; Harmonization; Prescription drug; Government (linguistics); Legislation; Public health","routes":{"ca_aff":false,"ca_fund":false,"ca_venue":false,"about_ca":true,"invisible_to_affiliation_only":true},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.001387105,0.001096329,0.0006296908,0.002991084,0.005439223,0.006733247,0.001432352,0.005913958,0.02768403],"category_scores_gemma":[0.002150425,0.0008420131,0.0006259764,0.002798188,0.003046181,0.00161167,0.0011288,0.005097201,0.008333674],"about_ca_system_candidate":true,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.04963257,"about_ca_system_score_gemma":0.0832988,"about_ca_topic_candidate":true,"about_ca_topic_consensus":true,"about_ca_topic_score_codex":0.8668884,"about_ca_topic_score_gemma":0.9413331,"domain_scores_codex":[0.9977022,0.0001702029,0.00006033119,0.0001775728,0.001543309,0.0003464469],"domain_scores_gemma":[0.9987172,0.0002672845,0.00004125125,0.0000582055,0.0008155096,0.0001006237],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"not_applicable","study_design_gemma":"not_applicable","study_design_scores_codex":[0.000007154496,0.00002451456,0.0001360568,0.00008901991,0.000003071665,0.00007037207,0.00034761,0.0003394494,0.0002153008,0.185062,0.7752736,0.03843203],"study_design_scores_gemma":[0.000001435926,0.000002423386,0.0002742936,0.00009408877,0.000001940309,0.00002022436,0.00005413719,0.00009473343,0.00007881634,0.003417635,0.9959521,0.000008213994],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"other","genre_gemma":"other","genre_scores_codex":[0.0005216009,0.01883077,0.001368768,0.01142022,0.002503088,0.0001660439,0.0006974385,0.0001606499,0.9643314],"genre_scores_gemma":[0.004084066,0.009464072,0.001525928,0.00484469,0.0002197639,0.00005737942,0.0001816878,0.00004695063,0.9795755],"genre_candidate":"other","genre_consensus":"other","teacher_disagreement_score":0.9503675,"threshold_uncertainty_score":0.3601112,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.01874031505103233,"score_gpt":0.3135626557906984,"score_spread":0.294822340739666,"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."}}