documents

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

7 rows where agency_id = "FDA" and docket_id = "FDA-1998-N-1290" sorted by posted_date descending

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posted_year 2

agency_id 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1998-N-1290-0007 FDA New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies are not Ethical or Feasible FDA-1998-N-1290 OMB Review on 10/5/99 - [New Drug and Biological Drug Products; Evidence Needed to Demonstrate Efficacy of New Drugs for Use Against Lethal or Permanently Disabling Toxic Substances When Efficacy Studies in Humans Ethically Cannot Be Conducted] - Reference Supporting & Related Material REF-Reference (internal unless indicated) 2009-04-23T04:00:00Z 2009 4     2009-04-24T00:57:34Z   0 0 09000064805a6f41
FDA-1998-N-1290-0006 FDA New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies are not Ethical or Feasible FDA-1998-N-1290 OMB Review on 5/31/02 - [New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible] - Reference Supporting & Related Material REF-Reference (internal unless indicated) 2009-04-23T04:00:00Z 2009 4     2009-04-24T00:57:33Z   0 0 09000064805a6f3f
FDA-1998-N-1290-0002 FDA New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies are not Ethical or Feasible FDA-1998-N-1290 New Drug and Biological Drug Products; Evidence Needed to Demonstrate Efficacy of New Drugs for Use Against Lethal or Permanently Disabling Toxic Substances When Efficacy Studies in Humans Ethically Cannot Be Conducted Proposed Rule NPR-Notice of Proposed Rule-Making 2009-04-23T04:00:00Z 2009 4 2009-04-23T04:00:00Z 1999-12-21T04:59:59Z 2009-04-24T00:57:14Z 99–25377 0 0 09000064805a6f34
FDA-1998-N-1290-0005 FDA New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies are not Ethical or Feasible FDA-1998-N-1290 OMB Information Collection - [New Drug and Biological Drug Products; Evidence Needed to Demonstrate Efficacy of New Drugs for Use Against Lethal or Permanently Disabling Toxic Substances When Efficacy Studies in Humans Ethically Cannot Be Conducted; Proposed Rule] - Supporting Statement Supporting & Related Material SS-Supporting Statement 2009-04-23T04:00:00Z 2009 4     2009-04-24T00:57:32Z   0 0 09000064805a6f3b
FDA-1998-N-1290-0004 FDA New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies are not Ethical or Feasible FDA-1998-N-1290 Reference List - [Evidence Needed To Demonstrate Efficacy of New Drugs for Use Against Lethal or Permanently Disabling Toxic Substances When Efficacy Studies in Humans Ethically Cannot Be Conducted] - Background Supporting & Related Material BKG-Background Material 2009-04-23T04:00:00Z 2009 4     2009-04-24T00:57:18Z   0 0 09000064805a6f37
FDA-1998-N-1290-0003 FDA New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies are not Ethical or Feasible FDA-1998-N-1290 Agency Information Collection Activities; Announcement of OMB Approval; New Drug and Biological Drug Products; Evidence Needed to Demonstrate Efficacy of New Drugs for Use Against Lethal or Permanently Disabling Toxic Substances When Efficacy Studies in Humans Ethically Cannot Be Conducted Notice NAL-Notice of Approval 2009-04-23T04:00:00Z 2009 4 2009-04-23T04:00:00Z   2009-04-24T00:57:15Z 00–991 0 0 09000064805a6f3c
FDA-1998-N-1290-0001 FDA New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies are not Ethical or Feasible FDA-1998-N-1290 New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible Rule NFR-Notice of Final Rule 2002-06-04T04:00:00Z 2002 6     2009-04-23T22:59:35Z   0 0 09000064805a6f2d

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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);