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

5 rows where docket_id = "FDA-2024-P-5965" sorted by posted_date descending

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

posted_year 2

document_type 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2024-P-5965-0860 FDA Requests the Food and Drug Administration (FDA) to take the following actions to accelerate access to Pritelivir, an investigational treatment for Herpes Simplex Virus (HSV) patients. 1. Grant Expanded Access (Compassionate Use) to Pritelivir under the existing Expanded Access Programs (EAP) to allow patients with severe or refractory HSV infections access to the drug. FDA-2024-P-5965 Response Letter from FDA CDER to Herpes Heroes Other Denial of Petition 2026-05-11T04:00:00Z 2026 5 2026-05-11T04:00:00Z   2026-05-11T19:36:34Z   0 0 09000064b92ca57c
FDA-2024-P-5965-0712 FDA Requests the Food and Drug Administration (FDA) to take the following actions to accelerate access to Pritelivir, an investigational treatment for Herpes Simplex Virus (HSV) patients. 1. Grant Expanded Access (Compassionate Use) to Pritelivir under the existing Expanded Access Programs (EAP) to allow patients with severe or refractory HSV infections access to the drug. FDA-2024-P-5965 Interim Response Letter from FDA CDER to Herpes Heroes Other Response(s) 2025-06-04T04:00:00Z 2025 6 2025-06-04T04:00:00Z   2025-06-04T16:29:39Z   0 0 09000064b8dd4dba
FDA-2024-P-5965-0002 FDA Requests the Food and Drug Administration (FDA) to take the following actions to accelerate access to Pritelivir, an investigational treatment for Herpes Simplex Virus (HSV) patients. 1. Grant Expanded Access (Compassionate Use) to Pritelivir under the existing Expanded Access Programs (EAP) to allow patients with severe or refractory HSV infections access to the drug. FDA-2024-P-5965 Acknowledgement Letter from FDA DMB to Herpes Heroes Other Acknowledgement Letter/Receipt 2025-01-02T05:00:00Z 2025 1 2025-01-02T05:00:00Z   2025-01-02T12:10:37Z   0 0 0900006486895ab1
FDA-2024-P-5965-0003 FDA Requests the Food and Drug Administration (FDA) to take the following actions to accelerate access to Pritelivir, an investigational treatment for Herpes Simplex Virus (HSV) patients. 1. Grant Expanded Access (Compassionate Use) to Pritelivir under the existing Expanded Access Programs (EAP) to allow patients with severe or refractory HSV infections access to the drug. FDA-2024-P-5965 Attachment 1 - Testimonial Exhibits Supporting & Related Material Background Material 2025-01-02T05:00:00Z 2025 1     2025-01-02T12:11:00Z   0 0 0900006486895ae7
FDA-2024-P-5965-0001 FDA Requests the Food and Drug Administration (FDA) to take the following actions to accelerate access to Pritelivir, an investigational treatment for Herpes Simplex Virus (HSV) patients. 1. Grant Expanded Access (Compassionate Use) to Pritelivir under the existing Expanded Access Programs (EAP) to allow patients with severe or refractory HSV infections access to the drug. FDA-2024-P-5965 Citizen Petition from Herpes Heroes Other Citizen Petition 2025-01-02T05:00:00Z 2025 1 2025-01-02T05:00:00Z   2026-02-26T10:00:12Z   1 0 0900006486895ab0

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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;