{"id":"W4214559639","doi":"10.1089/blr.2008.9935","title":"Third Circuit Accepts Preemption Arguments; More Cautions About Follow-On Biologics; Health Canada Issues Approval Guidance; FDA Takes First Steps in Expanding Drug Safety; Congress Proposes Requiring “Country of Origin” Statement; Congress Wants Direct Treatment Comparisons; Further Congressional Questions About Drug Advertising; Promised Studies Not Done; Warning over Avandia; Inspections of Foreign Facilities Will Not Be Easy; FDA Guidance on Genomics Term Definitions; European Scientists Want More Nanotechnology Regulation; Geron Stem Cell Trial on Hold; South Korea Clarifies Cloning Regulations; Decisions Needed on Antivirals in Advance of Flu Epidemic; Efforts to Control Genetic Testing; Bush Signs Genetic Information Nondiscrimination Act; Drug Companies Petition for Looser Restrictions on Literature on Off-Label Uses; Merck Said to Have Violated Publishing Ethics; Trade in Biotechnology Requires Closer Control; U.N. Alleges Chinese Dissidents Being Used as Organ Sources; Recent Approvals; Approval Delays?; NIH's Open Access Policy Still Has Publishers Roiled; Tilting at the FDA","year":2008,"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":"Preemption; Drug control; Federal preemption; Law; Medicine; Political science; Statute; Computer science","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","sts"],"consensus_categories":[],"category_scores_codex":[0.002160005,0.0007151972,0.001244014,0.002243506,0.0017143,0.0005617957,0.0008753585,0.00047412,0.000003444474],"category_scores_gemma":[0.005569765,0.0005617856,0.0001255348,0.001788842,0.0007796092,0.002077554,0.0003144665,0.0008743641,0.000001207106],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.001791568,"about_ca_system_score_gemma":0.0006148499,"about_ca_topic_candidate":true,"about_ca_topic_consensus":true,"about_ca_topic_score_codex":0.02531702,"about_ca_topic_score_gemma":0.06038737,"domain_scores_codex":[0.9939342,0.0005643205,0.002721004,0.001134373,0.0008770418,0.0007691094],"domain_scores_gemma":[0.9939482,0.001574708,0.002915618,0.0008064661,0.0006857423,0.00006927292],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"simulation_or_modeling","study_design_gemma":"observational","study_design_scores_codex":[0.0331777,0.003303585,0.1397707,0.001315073,0.0009131079,0.0001527258,0.04464813,0.7273267,0.03103302,0.01218319,0.001163125,0.005012934],"study_design_scores_gemma":[0.08834427,0.007324881,0.6095469,0.04266088,0.000694181,0.0001398622,0.04746789,0.03931388,0.1484884,0.002528713,0.008673376,0.004816811],"study_design_candidate":"simulation_or_modeling","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9827679,0.0002259023,0.000420039,0.008610766,0.0004778627,0.006506533,0.0006837379,0.0001595368,0.0001477216],"genre_scores_gemma":[0.9970701,0.0002275747,0.0005929452,0.0005222855,0.00006839965,0.0006676637,0.0006771764,0.00006546127,0.0001084009],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.6880128,"threshold_uncertainty_score":0.9996834,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1494701298097443,"score_gpt":0.3359656712391812,"score_spread":0.1864955414294369,"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."}}