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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

9 rows where docket_id = "FDA-2025-P-2170" sorted by posted_date descending

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

document_type 2

  • Supporting & Related Material 5
  • Other 4

posted_year 1

  • 2025 9

agency_id 1

  • FDA 9
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2025-P-2170-0009 FDA None FDA-2025-P-2170 Response Letter Other Letter(s) 2025-12-30T05:00:00Z 2025 12 2025-12-30T05:00:00Z   2025-12-31T00:38:33Z   0 0 09000064b91134cf
FDA-2025-P-2170-0008 FDA None FDA-2025-P-2170 Completeness Assessment Correspondence from FDA CDER to Lachman Consulting Services, Inc. Other Assessment Document or Analysis 2025-07-28T04:00:00Z 2025 7 2025-07-28T04:00:00Z   2025-07-28T21:32:07Z   0 0 09000064b8eb1469
FDA-2025-P-2170-0004 FDA None FDA-2025-P-2170 Attachment 2 - Prescribing Information for Vyndaqel and Vyndamax Supporting & Related Material Background Material 2025-07-07T04:00:00Z 2025 7     2025-07-08T02:20:51Z   0 0 09000064b8e5879e
FDA-2025-P-2170-0001 FDA None FDA-2025-P-2170 Suitability Petition from Lachman Consulting Services, Inc. Other Petition(s) 2025-07-07T04:00:00Z 2025 7 2025-07-07T04:00:00Z   2026-02-27T01:33:39Z   0 0 09000064b8e57252
FDA-2025-P-2170-0002 FDA None FDA-2025-P-2170 Acknowledgment Letter from FDA DMB to Lachman Consulting Services, Inc. Other Acknowledgement Letter/Receipt 2025-07-07T04:00:00Z 2025 7 2025-07-07T04:00:00Z   2025-07-08T02:20:35Z   0 0 09000064b8e57254
FDA-2025-P-2170-0003 FDA None FDA-2025-P-2170 Attachment 1 - Orange Book - Approved Drug Products with Therapeutic Equivalence Evaluations Supporting & Related Material Background Material 2025-07-07T04:00:00Z 2025 7     2025-07-08T02:20:44Z   0 0 09000064b8e5879d
FDA-2025-P-2170-0006 FDA None FDA-2025-P-2170 Attachment 4 - Hereditary Transthyretin Amyloidosis Supporting & Related Material Background Material 2025-07-07T04:00:00Z 2025 7     2025-07-08T02:21:09Z   0 0 09000064b8e587a0
FDA-2025-P-2170-0005 FDA None FDA-2025-P-2170 Attachment 3 - Prescribing Information for Tafamidis Tablets Supporting & Related Material Background Material 2025-07-07T04:00:00Z 2025 7     2025-07-08T02:21:00Z   0 0 09000064b8e5879f
FDA-2025-P-2170-0007 FDA None FDA-2025-P-2170 Attachment 5 - Highlights of Prescribing Information for Vyndaqel and Vyndamax Supporting & Related Material Background Material 2025-07-07T04:00:00Z 2025 7     2025-07-08T02:21:18Z   0 0 09000064b8e587a1

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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;
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