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

10 rows where docket_id = "FDA-2019-N-1363" sorted by posted_date descending

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Suggested facets: title, subtype, posted_date, posted_month, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2019-N-1363-0033 FDA None FDA-2019-N-1363 Reference 3 Bundling Multiple Devices or Multiple Indications in a Single Submission Guidance for Industry and Food and Drug Administration Staff Supporting & Related Material Background Material 2024-02-12T05:00:00Z 2024 2     2024-02-12T14:20:36Z   0 0 0900006486400aee
FDA-2019-N-1363-0031 FDA None FDA-2019-N-1363 Reference 1 Interpretation of the Deemed to be a License Provision of the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry Supporting & Related Material Background Material 2024-02-12T05:00:00Z 2024 2     2024-02-12T14:18:21Z   0 0 0900006486400aec
FDA-2019-N-1363-0032 FDA None FDA-2019-N-1363 Referece 2 Cooperative-Manufacturing Arrangements for Licensed Biologics Supporting & Related Material Background Material 2024-02-12T05:00:00Z 2024 2     2024-02-12T14:19:22Z   0 0 0900006486400aed
FDA-2019-N-1363-0035 FDA None FDA-2019-N-1363 Reference 5 Drug Master Files Guidance for Industry Supporting & Related Material Background Material 2024-02-12T05:00:00Z 2024 2     2024-02-12T14:22:39Z   0 0 0900006486400af0
FDA-2019-N-1363-0036 FDA None FDA-2019-N-1363 Reference 6 Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Supporting & Related Material Background Material 2024-02-12T05:00:00Z 2024 2     2024-02-12T14:24:06Z   0 0 0900006486400af1
FDA-2019-N-1363-0029 FDA None FDA-2019-N-1363 Biologics License Applications and Master Files Rule Final Rule 2024-02-12T05:00:00Z 2024 2 2024-02-12T05:00:00Z   2024-02-12T14:12:23Z 2024-02741 0 0 09000064864008a6
FDA-2019-N-1363-0030 FDA None FDA-2019-N-1363 List of References Supporting & Related Material Background Material 2024-02-12T05:00:00Z 2024 2     2024-02-12T14:16:49Z   0 0 0900006486400aeb
FDA-2019-N-1363-0034 FDA None FDA-2019-N-1363 Reference 4 Biosimilars Action Plan Supporting & Related Material Background Material 2024-02-12T05:00:00Z 2024 2     2024-02-12T14:21:40Z   0 0 0900006486400aef
FDA-2019-N-1363-0037 FDA None FDA-2019-N-1363 Reference 7 BLAs and Master Files Final Reg Impact Analysis Supporting & Related Material Background Material 2024-02-12T05:00:00Z 2024 2     2024-02-12T14:25:02Z   0 0 0900006486400af3
FDA-2019-N-1363-0001 FDA None FDA-2019-N-1363 Biologics License Applications and Master Files Proposed Rule Notice of Proposed Rulemaking (NPRM) 2019-06-28T04:00:00Z 2019 6 2019-06-28T04:00:00Z 2019-08-28T03:59:59Z 2019-08-28T01:03:12Z 2019-13753 0 0 0900006483d4af9c

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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;