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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

13 rows where docket_id = "FDA-2025-P-6315" sorted by posted_date descending

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posted_year 2

  • 2025 12
  • 2026 1

document_type 2

  • Supporting & Related Material 10
  • Other 3

agency_id 1

  • FDA 13
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-6315-0013 FDA Request that the FDA ensure that applications submitted under 505(j) and 505(b)(2) that rely on LEQVIO include data necessary to show that a proposed product is pharmaceutically equivalent and can be expected to have the same clinical effect and safety profile as LEQVIO when administered to patients under the conditions specified in the labeling FDA-2025-P-6315 Interim Response Other Letter(s) 2026-05-12T04:00:00Z 2026 5 2026-05-12T04:00:00Z   2026-05-12T18:26:15Z   0 0 09000064b92cfe1a
FDA-2025-P-6315-0003 FDA Request that the FDA ensure that applications submitted under 505(j) and 505(b)(2) that rely on LEQVIO include data necessary to show that a proposed product is pharmaceutically equivalent and can be expected to have the same clinical effect and safety profile as LEQVIO when administered to patients under the conditions specified in the labeling FDA-2025-P-6315 Tab 1 - Ranasinghe (2023) Final Supporting & Related Material Background Material 2025-11-19T05:00:00Z 2025 11     2025-11-19T21:08:04Z   0 0 09000064b9089443
FDA-2025-P-6315-0004 FDA Request that the FDA ensure that applications submitted under 505(j) and 505(b)(2) that rely on LEQVIO include data necessary to show that a proposed product is pharmaceutically equivalent and can be expected to have the same clinical effect and safety profile as LEQVIO when administered to patients under the conditions specified in the labeling FDA-2025-P-6315 Tab 2 - Draft Guidance on Inclirisan Sodium (2023) Supporting & Related Material Background Material 2025-11-19T05:00:00Z 2025 11     2025-11-19T21:08:08Z   0 0 09000064b9089444
FDA-2025-P-6315-0012 FDA Request that the FDA ensure that applications submitted under 505(j) and 505(b)(2) that rely on LEQVIO include data necessary to show that a proposed product is pharmaceutically equivalent and can be expected to have the same clinical effect and safety profile as LEQVIO when administered to patients under the conditions specified in the labeling FDA-2025-P-6315 Tab 10 - Kaushal (2023) Supporting & Related Material Background Material 2025-11-19T05:00:00Z 2025 11     2025-11-19T21:08:35Z   0 0 09000064b908946c
FDA-2025-P-6315-0007 FDA Request that the FDA ensure that applications submitted under 505(j) and 505(b)(2) that rely on LEQVIO include data necessary to show that a proposed product is pharmaceutically equivalent and can be expected to have the same clinical effect and safety profile as LEQVIO when administered to patients under the conditions specified in the labeling FDA-2025-P-6315 Tab 5 - FDA Citizen Petition Response (2009) Supporting & Related Material Background Material 2025-11-19T05:00:00Z 2025 11     2025-11-19T21:08:19Z   0 0 09000064b9089467
FDA-2025-P-6315-0006 FDA Request that the FDA ensure that applications submitted under 505(j) and 505(b)(2) that rely on LEQVIO include data necessary to show that a proposed product is pharmaceutically equivalent and can be expected to have the same clinical effect and safety profile as LEQVIO when administered to patients under the conditions specified in the labeling FDA-2025-P-6315 Tab 4 - Hu (2020) Supporting & Related Material Background Material 2025-11-19T05:00:00Z 2025 11     2025-11-19T21:08:15Z   0 0 09000064b9089466
FDA-2025-P-6315-0008 FDA Request that the FDA ensure that applications submitted under 505(j) and 505(b)(2) that rely on LEQVIO include data necessary to show that a proposed product is pharmaceutically equivalent and can be expected to have the same clinical effect and safety profile as LEQVIO when administered to patients under the conditions specified in the labeling FDA-2025-P-6315 Tab 6 - Iwamoto (2017) Supporting & Related Material Background Material 2025-11-19T05:00:00Z 2025 11     2025-11-19T21:08:22Z   0 0 09000064b9089468
FDA-2025-P-6315-0011 FDA Request that the FDA ensure that applications submitted under 505(j) and 505(b)(2) that rely on LEQVIO include data necessary to show that a proposed product is pharmaceutically equivalent and can be expected to have the same clinical effect and safety profile as LEQVIO when administered to patients under the conditions specified in the labeling FDA-2025-P-6315 Tab 9 - Dowdy (2023) Supporting & Related Material Background Material 2025-11-19T05:00:00Z 2025 11     2025-11-19T21:08:31Z   0 0 09000064b908946b
FDA-2025-P-6315-0009 FDA Request that the FDA ensure that applications submitted under 505(j) and 505(b)(2) that rely on LEQVIO include data necessary to show that a proposed product is pharmaceutically equivalent and can be expected to have the same clinical effect and safety profile as LEQVIO when administered to patients under the conditions specified in the labeling FDA-2025-P-6315 Tab 7 - Arrico (2022) Supporting & Related Material Background Material 2025-11-19T05:00:00Z 2025 11     2025-11-19T21:08:25Z   0 0 09000064b9089469
FDA-2025-P-6315-0002 FDA Request that the FDA ensure that applications submitted under 505(j) and 505(b)(2) that rely on LEQVIO include data necessary to show that a proposed product is pharmaceutically equivalent and can be expected to have the same clinical effect and safety profile as LEQVIO when administered to patients under the conditions specified in the labeling FDA-2025-P-6315 Acknowledgement Letter from FDA DMB to Novartis Pharmaceuticals Corporation Other Acknowledgement Letter/Receipt 2025-11-19T05:00:00Z 2025 11 2025-11-19T05:00:00Z   2025-11-19T21:07:51Z   0 0 09000064b9089441
FDA-2025-P-6315-0001 FDA Request that the FDA ensure that applications submitted under 505(j) and 505(b)(2) that rely on LEQVIO include data necessary to show that a proposed product is pharmaceutically equivalent and can be expected to have the same clinical effect and safety profile as LEQVIO when administered to patients under the conditions specified in the labeling FDA-2025-P-6315 Citizen Petition from Novartis Pharmaceuticals Corporation Other Citizen Petition 2025-11-19T05:00:00Z 2025 11 2025-11-19T05:00:00Z   2025-11-19T21:07:33Z   1 0 09000064b908943f
FDA-2025-P-6315-0010 FDA Request that the FDA ensure that applications submitted under 505(j) and 505(b)(2) that rely on LEQVIO include data necessary to show that a proposed product is pharmaceutically equivalent and can be expected to have the same clinical effect and safety profile as LEQVIO when administered to patients under the conditions specified in the labeling FDA-2025-P-6315 Tab 8 - Jahns (2022) Supporting & Related Material Background Material 2025-11-19T05:00:00Z 2025 11     2025-11-19T21:08:28Z   0 0 09000064b908946a
FDA-2025-P-6315-0005 FDA Request that the FDA ensure that applications submitted under 505(j) and 505(b)(2) that rely on LEQVIO include data necessary to show that a proposed product is pharmaceutically equivalent and can be expected to have the same clinical effect and safety profile as LEQVIO when administered to patients under the conditions specified in the labeling FDA-2025-P-6315 Tab 3 - Ebenezer (2023) Supporting & Related Material Background Material 2025-11-19T05:00:00Z 2025 11     2025-11-19T21:08:12Z   0 0 09000064b9089445

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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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