{"id":"W1463745293","doi":"10.24926/15529541.3697","title":"Can Regulation be as Innovative as Science and Technology? The FDA's Regulation of Combination Products","year":2005,"lang":"en","type":"article","venue":"Minnesota journal of law, science & technology","topic":"Biomedical Ethics and Regulation","field":"Medicine","cited_by":29,"is_retracted":false,"has_abstract":true,"ca_institutions":"Institute of Health Services and Policy Research","funders":"","keywords":"Food and drug administration; Regulatory science; Legislature; Variety (cybernetics); Engineering ethics; Business; Product (mathematics); Regulatory affairs; Risk analysis (engineering); Gene technology; Medicine; Biotechnology; Engineering; Political science; Computer science; Law; Biology","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":"codex-gemma-dda1882f352a","candidate_categories":["sts"],"consensus_categories":[],"category_scores_codex":[0.003820327,0.0001324404,0.0002907669,0.002511537,0.0005298443,0.00003819056,0.0005345535,0.0003006925,0.00001438181],"category_scores_gemma":[0.002688296,0.00008659605,0.00002181126,0.01153183,0.02424789,0.0005623383,0.00017796,0.0005201754,0.000001514673],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0002878066,"about_ca_system_score_gemma":0.001767326,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0000201825,"about_ca_topic_score_gemma":0.00002155744,"domain_scores_codex":[0.997253,0.00002687668,0.0006419785,0.0003330859,0.001438901,0.0003061807],"domain_scores_gemma":[0.9922658,0.00004982332,0.0008058018,0.0004082582,0.006383395,0.00008687699],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"bench_or_experimental","study_design_gemma":"bench_or_experimental","study_design_scores_codex":[0.00002861828,0.00008408442,0.0004984615,0.00001471204,0.000006853638,0.000002313718,0.0004067391,0.000004919991,0.4972587,0.4691337,0.00005249848,0.03250837],"study_design_scores_gemma":[0.001233164,0.001506632,0.02290044,0.0002233315,0.00005616375,0.001852585,0.0009772889,0.001475993,0.8280982,0.1302984,0.01122779,0.0001499956],"study_design_candidate":"bench_or_experimental","study_design_consensus":"bench_or_experimental","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.6627889,0.0002385195,0.0001230593,0.3356653,0.0001343661,0.0002551569,7.977212e-7,0.00002553914,0.0007684284],"genre_scores_gemma":[0.9968398,0.00004440134,0.002463912,0.0004407365,0.00007293527,0.000004114543,0.000001498337,0.00000774254,0.0001249056],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.3388353,"threshold_uncertainty_score":0.9784076,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.01541669891818411,"score_gpt":0.2982455711496779,"score_spread":0.2828288722314938,"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."}}