{"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":"metacan-v3-hybrid-931329e0061c","candidate_categories":["metaresearch","research_integrity"],"consensus_categories":[],"category_scores_codex":[0.007838882,0.001097722,0.001385971,0.001946908,0.01700295,0.01608806,0.004474525,0.05781,0.02102344],"category_scores_gemma":[0.0349744,0.001046392,0.003449615,0.001914088,0.006298506,0.007683945,0.002657066,0.03161863,0.007855016],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.01147795,"about_ca_system_score_gemma":0.01954313,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.1471663,"about_ca_topic_score_gemma":0.1955335,"domain_scores_codex":[0.9898953,0.001070603,0.0005759315,0.001435835,0.004517978,0.002504387],"domain_scores_gemma":[0.9775518,0.01333588,0.0005104296,0.0008866173,0.006908793,0.0008065759],"domain_codex":null,"domain_gemma":"evaluation","domain_candidate":"evaluation","domain_consensus":null,"study_design_codex":"not_applicable","study_design_gemma":"not_applicable","study_design_scores_codex":[0.00006133592,0.00006761508,0.0006158265,0.00005111648,0.00001800738,0.0003050115,0.0006041748,0.0001438949,0.0003773159,0.4381671,0.5528845,0.006704004],"study_design_scores_gemma":[0.0001452856,0.00007116818,0.001538975,0.0002118312,0.0001310763,0.0001850005,0.0005933058,0.000823458,0.00132159,0.06569674,0.929163,0.0001186432],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"commentary","genre_gemma":"commentary","genre_scores_codex":[0.004615912,0.001526654,0.003432046,0.5635001,0.007727633,0.0001257548,0.00100481,0.000522733,0.4175443],"genre_scores_gemma":[0.05474761,0.0007767573,0.004040034,0.7384337,0.003900962,0.0003426387,0.0002519987,0.0002251735,0.1972811],"genre_candidate":"commentary","genre_consensus":"commentary","teacher_disagreement_score":0.9921611,"threshold_uncertainty_score":0.2926194,"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."}}