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

8 rows where docket_id = "FDA-1995-D-0288" and posted_year = 2021 sorted by posted_date descending

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  • 2021 · 8 ✖

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1995-D-0288-0051 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 Ref. 7 - Q12 Technical and Regulatory Considerations for Pharmaceutical Producte Lyfecycle Managment Annex May 2021 RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry Supporting & Related Material Background Material 2021-07-07T04:00:00Z 2021 7     2021-07-07T12:23:19Z   0 0 0900006484bd4b2d
FDA-1995-D-0288-0053 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 Ref. 9 - Comparability Protocols for Human Drugs and Biologics April 2016 RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry Supporting & Related Material Background Material 2021-07-07T04:00:00Z 2021 7     2021-07-07T12:23:31Z   0 0 0900006484bd4b2f
FDA-1995-D-0288-0054 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 Ref. 15 - Good Review Managment Principles and Practice for New Drug Applications and Biologics License Sept 2018 RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry Supporting & Related Material Background Material 2021-07-07T04:00:00Z 2021 7     2021-07-07T12:23:37Z   0 0 0900006484bd4b30
FDA-1995-D-0288-0052 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 Ref. 7 - ICH Q 12 Annex RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry Supporting & Related Material Background Material 2021-07-07T04:00:00Z 2021 7     2021-07-07T12:23:25Z   0 0 0900006484bd4b2e
FDA-1995-D-0288-0055 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 Ref. 23 - Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research March 2019 RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry Supporting & Related Material Background Material 2021-07-07T04:00:00Z 2021 7     2021-07-07T12:23:44Z   0 0 0900006484bd4b31
FDA-1995-D-0288-0050 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 PAC FINAL GUIDANCE reference list RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry Supporting & Related Material Background Material 2021-07-07T04:00:00Z 2021 7     2021-07-07T12:23:11Z   0 0 0900006484bcd0c7
FDA-1995-D-0288-0049 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry Other Guidance 2021-06-24T04:00:00Z 2021 6 2021-06-24T04:00:00Z   2024-11-12T23:32:40Z   1 0 0900006484baa9ff
FDA-1995-D-0288-0048 FDA Changes to be Reported for Product and Establishment License Application; Guidance FDA-1995-D-0288 Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry; Availability Notice Notice of Availability 2021-06-24T04:00:00Z 2021 6 2021-06-24T04:00:00Z   2021-06-24T14:02:39Z 2021-13392 0 0 0900006484ba948e

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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);