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

6 rows where docket_id = "FDA-2018-N-3240" and posted_year = 2023 sorted by posted_date descending

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posted_year 1

  • 2023 · 6 ✖

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2018-N-3240-0376 FDA None FDA-2018-N-3240 Reference 1 - FDA Proposal Not to Include Ephedrine Sulfate on the 503B Bulks List RE List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Supporting & Related Material Background Material 2023-08-28T04:00:00Z 2023 8     2023-08-28T16:19:35Z   0 0 0900006485f02240
FDA-2018-N-3240-0375 FDA None FDA-2018-N-3240 Reference 3 - Part 1 Evaluation for Hydroxychloroquine Sulfate RE List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Supporting & Related Material Background Material 2023-08-23T04:00:00Z 2023 8     2023-08-23T20:14:40Z   0 0 0900006485edb7aa
FDA-2018-N-3240-0374 FDA None FDA-2018-N-3240 Reference 2 - Supplemental clinical need evaluation for ephedrine sulfate in compounding under section 503B of the Federal Food, Drug, and Cosmetic Act RE List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Supporting & Related Material Background Material 2023-08-21T04:00:00Z 2023 8     2023-08-21T19:04:48Z   0 0 0900006485ecb128
FDA-2018-N-3240-0373 FDA None FDA-2018-N-3240 List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Notice General Notice 2023-08-21T04:00:00Z 2023 8     2023-08-21T12:58:21Z 2023-17881 0 0 0900006485ec9ee6
FDA-2018-N-3240-0371 FDA None FDA-2018-N-3240 List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Notice Announcement 2023-04-06T04:00:00Z 2023 4 2023-04-06T04:00:00Z   2023-04-10T14:30:49Z 2023-07217 0 0 09000064858f25e1
FDA-2018-N-3240-0372 FDA None FDA-2018-N-3240 Reference 4 re: List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic Prescription Requirements Under Section 503 A Under the Federal Food Drug and Cosmetic Act Supporting & Related Material Background Material 2023-04-06T04:00:00Z 2023 4     2023-04-06T15:50:49Z   0 0 09000064858f2ed2

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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;