{"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":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.0006200984,0.0003809794,0.0002570777,0.001244824,0.001605927,0.001539317,0.0005869827,0.002558192,0.05177227],"category_scores_gemma":[0.001119701,0.0003112146,0.0004158444,0.0004299454,0.000917449,0.0005419754,0.0004251196,0.00193569,0.01090629],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.003215614,"about_ca_system_score_gemma":0.004567128,"about_ca_topic_candidate":true,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.05628832,"about_ca_topic_score_gemma":0.203482,"domain_scores_codex":[0.9995263,0.00002669925,0.00001047918,0.00004680237,0.0003050361,0.0000847066],"domain_scores_gemma":[0.9993944,0.0001142563,0.00005260123,0.00005923327,0.0002607127,0.0001186963],"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":[0.0003573843,0.0002503761,0.002512553,0.0002576987,0.00003887905,0.001503755,0.0003430451,0.0001979534,0.04703433,0.05227821,0.7606055,0.1346203],"study_design_scores_gemma":[0.00006618477,0.00009543131,0.003097662,0.00007804215,0.00002137181,0.0005075571,0.00005052364,0.00009696455,0.008376987,0.001527282,0.9860686,0.00001332884],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"other","genre_gemma":"other","genre_scores_codex":[0.01410846,0.010587,0.006230764,0.01855734,0.002359439,0.0003805006,0.0046977,0.001675762,0.941403],"genre_scores_gemma":[0.08378611,0.004764364,0.006624137,0.0114692,0.0003259763,0.0001222392,0.002657933,0.0002996369,0.8899503],"genre_candidate":"other","genre_consensus":"other","teacher_disagreement_score":0.9437117,"threshold_uncertainty_score":0.1731955,"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."}}