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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

40 rows where docket_id = "FDA-2025-P-4282" sorted by posted_date descending

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posted_year 2

  • 2026 38
  • 2025 2

document_type 2

  • Supporting & Related Material 38
  • Other 2

agency_id 1

  • FDA 40
id agency_id docket_id title document_type subtype posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2025-P-4282-0172 FDA None FDA-2025-P-4282 Reference 27 - Large - Violence in first-episode psychosis A systematic review and meta-analysis Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:44:10Z   0 0 09000064b91d3d7f
FDA-2025-P-4282-0154 FDA None FDA-2025-P-4282 Reference 9 - Chalasani - Clozapine Impact on Clinical Outcomes and Aggression in Severely Ill Adolescents with Childhood-Onset Schizophrenia Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:43:18Z   0 0 09000064b91d3d6d
FDA-2025-P-4282-0160 FDA None FDA-2025-P-4282 Reference 15 - di Giacomo et al - Prescribing Patterns of Psychotropic Drugs and Risk of Violent Behavior Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:43:36Z   0 0 09000064b91d3d73
FDA-2025-P-4282-0164 FDA None FDA-2025-P-4282 Reference 19 - Fazel et al - Schizophrenia and Violence Systematic Review and Meta-Analysis Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:43:49Z   0 0 09000064b91d3d77
FDA-2025-P-4282-0167 FDA None FDA-2025-P-4282 Reference 22 - Galletly - Royal Australian and New Zealand College of Psychiatrists Clinical Practice Guidelines Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:43:57Z   0 0 09000064b91d3d7a
FDA-2025-P-4282-0148 FDA None FDA-2025-P-4282 Reference 4 - Bitter - Effectiveness of Clozapine Olanzapine Quetiapine Risperidone and Haloperidol Monotherapy Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:42:58Z   0 0 09000064b91d0f90
FDA-2025-P-4282-0151 FDA None FDA-2025-P-4282 Reference 7 - Cavaliere - Anti-Aggressive Effects of Clozapine in Involuntarily Committed Black Patients with Severe Mental Illness Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:43:09Z   0 0 09000064b91d0f93
FDA-2025-P-4282-0178 FDA None FDA-2025-P-4282 Reference 33 - Sariaslan - Associations between individual antipsychotics and the Risk of Arrests and Convictions of Violent and Other Crime Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:44:30Z   0 0 09000064b91d3d85
FDA-2025-P-4282-0150 FDA None FDA-2025-P-4282 Reference 6 - Buckley - Violence and Schizophrenia Clozapine as a Specific Antiaggressive Agent Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:43:05Z   0 0 09000064b91d0f92
FDA-2025-P-4282-0156 FDA None FDA-2025-P-4282 Reference 11 - Citrome - Specific Anti-hostility Effects of Atypical Antipsychotics in Persons with Schizophrenia Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:43:24Z   0 0 09000064b91d3d6f
FDA-2025-P-4282-0158 FDA None FDA-2025-P-4282 Reference 13 - de Domenico - The effect of clozapine of aggressive behaviour in patients with chronic schizophrenia Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:43:30Z   0 0 09000064b91d3d71
FDA-2025-P-4282-0169 FDA None FDA-2025-P-4282 Reference 24 - Herman - Clinical Response to Clozapine Treatment of 11 Chronic Patients in a State Psychiatric Hospital Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:44:02Z   0 0 09000064b91d3d7c
FDA-2025-P-4282-0155 FDA None FDA-2025-P-4282 Reference 10 - Chiles - Effects of Clozapine on Use of Seclusion and Restraint at a State Hospital Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:43:21Z   0 0 09000064b91d3d6e
FDA-2025-P-4282-0159 FDA None FDA-2025-P-4282 Reference 14 - Dennis - Clozapine Therapy in a State Hospital Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:43:33Z   0 0 09000064b91d3d72
FDA-2025-P-4282-0163 FDA None FDA-2025-P-4282 Reference 18 - Fazel Grann - The Population Impact of Severe Mental Illness on Violent Crime Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:43:46Z   0 0 09000064b91d3d76
FDA-2025-P-4282-0168 FDA None FDA-2025-P-4282 Reference 23 - Gammon - Clozapine Why Is It So Uniquely Effective in the Treatment ofa Range of Neuropsychiatric Disorders Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:44:00Z   0 0 09000064b91d3d7b
FDA-2025-P-4282-0182 FDA None FDA-2025-P-4282 Reference 37 - Wagner et al - Clozapine Optimization A Delphi Consensus Guideline From the Treatment Response and Resistance in Psychosis Working Group Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:44:42Z   0 0 09000064b91d3d89
FDA-2025-P-4282-0152 FDA None FDA-2025-P-4282 Reference 8 - Clozapine Impact on Clinical Outcomes and Aggression in Severly Ill Adolescents with Childhood-Onset Schizophrenia Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:43:12Z   0 0 09000064b91d3d6b
FDA-2025-P-4282-0171 FDA None FDA-2025-P-4282 Reference 26 - Kranzler - Clozapine Its Impact on Aggressive Behavior Among Children and Adolescents with Schizophrenia Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:44:08Z   0 0 09000064b91d3d7e
FDA-2025-P-4282-0173 FDA None FDA-2025-P-4282 Reference 28 - Newman - Management of Aggression Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:44:13Z   0 0 09000064b91d3d80
FDA-2025-P-4282-0175 FDA None FDA-2025-P-4282 Reference 30 - Potkin - Predicting Suicidal Risk in Schizophrenic and Schizoaffective Patients in a Prospective Two-Year Trial Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:44:19Z   0 0 09000064b91d3d82
FDA-2025-P-4282-0179 FDA None FDA-2025-P-4282 Reference 34 - Shaheen - The Effect of Clozapine on Violence - Aggression in Adults with Mental Illness and Personality Disorders Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:44:33Z   0 0 09000064b91d3d86
FDA-2025-P-4282-0181 FDA None FDA-2025-P-4282 Reference 36 - Volavka - Efficacy of Clozapine Olanzapine Risperidone and Haloperidol in Schizophrenia and Schizoaffective Disorder Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:44:39Z   0 0 09000064b91d3d88
FDA-2025-P-4282-0146 FDA None FDA-2025-P-4282 Reference 2 - Barnes - Evidence-based Guidelines for the Pharmacological Treatment of Schizophrenia Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:42:51Z   0 0 09000064b91d0f8e
FDA-2025-P-4282-0176 FDA None FDA-2025-P-4282 Reference 31 - Rabinowitz - Effect of clozapine on physical and verbal aggression Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:44:23Z   0 0 09000064b91d3d83
FDA-2025-P-4282-0166 FDA None FDA-2025-P-4282 Reference 21 - Frogley - A systematic review of the evidence of clozapines anti-aggressive effects Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:43:54Z   0 0 09000064b91d3d79
FDA-2025-P-4282-0180 FDA None FDA-2025-P-4282 Reference 35 - Volavka - Atypical antipsychotics in the treatment of the persistently aggressive psychotic patient Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:44:36Z   0 0 09000064b91d3d87
FDA-2025-P-4282-0177 FDA None FDA-2025-P-4282 Reference 32 - Reid - Internet Archive Interlibrary Loan Fulfillment Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:44:27Z   0 0 09000064b91d3d84
FDA-2025-P-4282-0149 FDA None FDA-2025-P-4282 Reference 5 - Buchanan - The 2009 Schizophrenia PORT Psychopharmacological Treatment Recommendations and Summary Statements Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:43:01Z   0 0 09000064b91d0f91
FDA-2025-P-4282-0153 FDA None FDA-2025-P-4282 Reference 8a - Chengappa - Clozapine Its impact on Aggressive Behavior Among Patients in a State Psychiatric Hospital Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:43:15Z   0 0 09000064b91d3d6c
FDA-2025-P-4282-0157 FDA None FDA-2025-P-4282 Reference 12 - Citrome - Effects of Clozapine Olanzapine Risperidone and Haloperidol on Hostility Among Patients with Schizophrenia Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:43:27Z   0 0 09000064b91d3d70
FDA-2025-P-4282-0161 FDA None FDA-2025-P-4282 Reference 16 - Ebrahim - Patient Response to Clozapine in a Forensic Psychiatric Hospital Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:43:41Z   0 0 09000064b91d3d74
FDA-2025-P-4282-0165 FDA None FDA-2025-P-4282 Reference 20 - Fazel et al - Violent crime suicide and premature mortality in patients with schizophrenia and related disorders Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:43:51Z   0 0 09000064b91d3d78
FDA-2025-P-4282-0170 FDA None FDA-2025-P-4282 Reference 25 - Keepers - The American Psychiatric Association Practice Guideline for the Treatment of Patients with Schizophrenia Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:44:05Z   0 0 09000064b91d3d7d
FDA-2025-P-4282-0174 FDA None FDA-2025-P-4282 Reference 29 - Nolan - Aggression and psychopathology in treatment-resistant inpatients with schizophrenia and Schizoaffective Disorder Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:44:16Z   0 0 09000064b91d3d81
FDA-2025-P-4282-0145 FDA None FDA-2025-P-4282 Reference 1 - Balbuena - Does Clozapine Promote Employability and Reduce Offending Among Mentally Disordered Offenders Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:42:48Z   0 0 09000064b91d0f8d
FDA-2025-P-4282-0147 FDA None FDA-2025-P-4282 Reference 3 - Bhavsar - Clozapine Treatment and Offending A Within-Subject Study of Patients With Psychotic Disorders in Sweden Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:42:54Z   0 0 09000064b91d0f8f
FDA-2025-P-4282-0162 FDA None FDA-2025-P-4282 Reference 17 - Faden - A systematic review of clozapine for aggression and violence in patients with schizophrenia or schizoaffective disorder Supporting & Related Material Background Material 2026-02-24T05:00:00Z 2026 2     2026-02-25T02:43:43Z   0 0 09000064b91d3d75
FDA-2025-P-4282-0001 FDA None FDA-2025-P-4282 Citizen Petition from Gilbert Honigfeld Other Citizen Petition 2025-09-25T04:00:00Z 2025 9 2025-09-25T04:00:00Z   2026-01-10T13:14:10Z   1 0 09000064b8fdcd91
FDA-2025-P-4282-0002 FDA None FDA-2025-P-4282 Acknowledgement Letter from FDA DMB to Gilbert Honigfeld Other Acknowledgement Letter/Receipt 2025-09-25T04:00:00Z 2025 9 2025-09-25T04:00:00Z   2025-09-25T19:20:21Z   0 0 09000064b8fdcda7

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;
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