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

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20 rows where docket_id = "FDA-2017-P-5787" and posted_year = 2020 sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2017-P-5787-0231 FDA None FDA-2017-P-5787 Melcangi_Methylation of SRD5A2 in CSF of PFS Pts (Endocr Connect 2019) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T16:07:15Z   0 0 0900006484984797
FDA-2017-P-5787-0222 FDA None FDA-2017-P-5787 CMDh Recommendation re Anxiety in Propecia SPC_EMA (Apr 2018) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T15:27:24Z   0 0 0900006484984768
FDA-2017-P-5787-0223 FDA None FDA-2017-P-5787 Diviccaro_Finasteride, Hippocampal Neurogenesis and Neuroinflammation in Rats (Psychneuroendocrin 2019) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T15:28:17Z   0 0 0900006484984769
FDA-2017-P-5787-0230 FDA None FDA-2017-P-5787 Levine_Court let Merck hide secrets (Reuters 9-11-19) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T16:06:26Z   0 0 0900006484984796
FDA-2017-P-5787-0232 FDA None FDA-2017-P-5787 Nguyen and Trinh_Suicidality and Psychological AEs w Finasteride (JAMA Derm 2020) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T16:09:31Z   0 0 0900006484984798
FDA-2017-P-5787-0241 FDA None FDA-2017-P-5787 Summary of Product Characteristics_ANSM_English (Dec 2019) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T16:34:25Z   0 0 090000648498449a
FDA-2017-P-5787-0224 FDA None FDA-2017-P-5787 Gulbinovic_Final Assessment Report of PSUR (Sweden MPA 2007) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T15:29:58Z   0 0 0900006484984791
FDA-2017-P-5787-0235 FDA None FDA-2017-P-5787 Petition Supplement 2 Post-Finasteride Syndrome Foundation Notice Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T17:17:17Z   0 0 0900006484984494
FDA-2017-P-5787-0226 FDA None FDA-2017-P-5787 Kaufman_Finasteride Rx for AGA (J Am Acad Dermatol 1998) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T15:31:57Z   0 0 0900006484984793
FDA-2017-P-5787-0228 FDA None FDA-2017-P-5787 Khera and Mirabel_Penile Vascular Abnormalities in PFS (Translat Androl Urol 2020) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T15:46:53Z   0 0 0900006484984794
FDA-2017-P-5787-0236 FDA None FDA-2017-P-5787 Propecia Proposed Prescribing Info_Revision Marks (2002) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T16:27:53Z   0 0 0900006484984495
FDA-2017-P-5787-0238 FDA None FDA-2017-P-5787 Propecia Summary of Product Characteristics_MHRA UK (Jun 2018) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T16:29:49Z   0 0 0900006484984497
FDA-2017-P-5787-0240 FDA None FDA-2017-P-5787 Reminder of Risk of Psychiatric and Sexual Disorders_ANSM webpage (Feb 2019) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T16:33:26Z   0 0 0900006484984499
FDA-2017-P-5787-0237 FDA None FDA-2017-P-5787 Propecia Summary of Product Characteristics_ANSM France (Dec 2019) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T16:28:52Z   0 0 0900006484984496
FDA-2017-P-5787-0225 FDA None FDA-2017-P-5787 Irwig_Finasteride and Suicide Case Series (Dermatol 2020) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T15:30:45Z   0 0 0900006484984792
FDA-2017-P-5787-0229 FDA None FDA-2017-P-5787 Letter to Health Professionals_Reminder of Risk of Psychiatric and Sexual Disorders_ANSM France (Feb 2019) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T15:52:35Z   0 0 0900006484984795
FDA-2017-P-5787-0227 FDA None FDA-2017-P-5787 Godar and Bortolato_Finasteride Reduces Response to Stressful and Rewarding Stimuli (Biomolec 2019) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T15:41:44Z   0 0 0900006484984790
FDA-2017-P-5787-0233 FDA None FDA-2017-P-5787 Periodic Safety Update Report _19_Merck (Nov 2006) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T16:24:23Z   0 0 0900006484984799
FDA-2017-P-5787-0234 FDA None FDA-2017-P-5787 Petition Supplement 1 Post-Finasteride Syndrome Foundation Notice Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T17:16:41Z   0 0 0900006484984493
FDA-2017-P-5787-0239 FDA None FDA-2017-P-5787 Red Hand Letter re Finasteride_BfArM Germany (Jul 2018) Supporting & Related Material Background Material 2020-12-03T05:00:00Z 2020 12     2020-12-03T16:30:50Z   0 0 0900006484984498

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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;