{"id":"W4252964882","doi":"10.1089/blr.2006.25.389","title":"First Product from Transgenic Animal Cleared in Europe; Mab Associated with Brain Infection Allowed Back on Market; Should U.S. Approve Follow-On Biologics?; D.C. Court of Appeals Finds Constitutional Right to Unapproved Drugs; Participating in Efforts Against Counterfeiters; Specifications Issued for Veterinary Biologics and Biotechnology Products; Electronic Communications Are Desirable for Important Drug Information; Guidance for Antiviral Drug Development; Short Stories: New Indication for Remicade; Bone Stimulant Approved in Canada","year":2006,"lang":"en","type":"article","venue":"Biotechnology Law Report","topic":"Intellectual Property and Patents","field":"Business, Management and Accounting","cited_by":0,"is_retracted":false,"has_abstract":false,"ca_institutions":"","funders":"","keywords":"Clearance; Product (mathematics); Supreme court; Medicine; Food and drug administration; Law; Political science; Pharmacology","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":"codex-gemma-dda1882f352a","candidate_categories":["metaepi_narrow"],"consensus_categories":[],"category_scores_codex":[0.001331451,0.0003324698,0.0005604976,0.000453349,0.0002934066,0.00004469182,0.0003235835,0.0003111595,0.000002389187],"category_scores_gemma":[0.001347446,0.0002960385,0.00004660674,0.0008888572,0.0002933661,0.000309284,0.00008353218,0.0002981845,5.415686e-7],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0005660207,"about_ca_system_score_gemma":0.0006160145,"about_ca_topic_candidate":true,"about_ca_topic_consensus":true,"about_ca_topic_score_codex":0.01888967,"about_ca_topic_score_gemma":0.2179511,"domain_scores_codex":[0.9972606,0.0000394823,0.001319276,0.0006674213,0.0001518378,0.0005614064],"domain_scores_gemma":[0.9979452,0.0003404561,0.0008763847,0.0004682194,0.0003520571,0.00001763148],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"observational","study_design_gemma":"not_applicable","study_design_scores_codex":[0.0556182,0.007583232,0.3658703,0.005908723,0.001793993,0.00008300597,0.003196505,0.01001938,0.3319185,0.1658359,0.0391229,0.01304933],"study_design_scores_gemma":[0.02145621,0.003326911,0.06056757,0.003659903,0.0003261319,0.00003069938,0.001429695,0.09818447,0.2723038,0.005873271,0.528994,0.003847398],"study_design_candidate":"bench_or_experimental","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9810459,0.00008298546,0.004894502,0.007133791,0.0001032135,0.006278312,0.0002601386,0.00009466443,0.0001064923],"genre_scores_gemma":[0.9907715,0.00002572226,0.004404964,0.0003159665,0.000043801,0.001880492,0.002491334,0.00002743876,0.00003876485],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.4898711,"threshold_uncertainty_score":0.9999492,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.0803028059876358,"score_gpt":0.2432839347296266,"score_spread":0.1629811287419908,"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."}}