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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

29 rows where docket_id = "FDA-2008-N-0474" and posted_year = 2015 sorted by posted_date descending

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document_type 3

  • Supporting & Related Material 21
  • Other 7
  • Proposed Rule 1

posted_year 1

  • 2015 · 29 ✖

agency_id 1

  • FDA 29
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2008-N-0474-0037 FDA None FDA-2008-N-0474 Letter from FDA CDER to L'Oreal USA Products, Inc. Other Letter(s) 2015-12-14T05:00:00Z 2015 12 2015-12-14T05:00:00Z   2015-12-14T20:53:46Z   0 0 0900006481da43dc
FDA-2008-N-0474-0036 FDA None FDA-2008-N-0474 Letter from L'Oreal USA Products Inc. to FDA CDER Other Letter(s) 2015-10-13T04:00:00Z 2015 10 2015-10-13T04:00:00Z   2015-10-13T13:22:00Z   0 0 0900006481cc3e87
FDA-2008-N-0474-0035 FDA None FDA-2008-N-0474 Advice Letter from FDA CDER to L'Oreal USA Products Inc Other Letter(s) 2015-09-02T04:00:00Z 2015 9 2015-09-02T04:00:00Z   2015-09-02T15:26:52Z   0 0 0900006481c50275
FDA-2008-N-0474-0034 FDA None FDA-2008-N-0474 Response to FDA Meeting Minutes May 11. 2015 from L'Oreal USA Other Minutes 2015-07-21T04:00:00Z 2015 7 2015-07-21T04:00:00Z   2015-07-21T15:05:49Z   0 0 0900006481b954ba
FDA-2008-N-0474-0033 FDA None FDA-2008-N-0474 Memorandum of Meeting Minutes May 11, 2015 between FDA CDER and L'Oreal USA Products Inc. Other Memorandum 2015-06-12T04:00:00Z 2015 6 2015-06-12T04:00:00Z   2015-06-12T14:51:44Z   0 0 0900006481b30d22
FDA-2008-N-0474-0029 FDA None FDA-2008-N-0474 Request for a Meeting from L'Oreal USA Products, Inc to FDA CDER Other Request 2015-05-01T04:00:00Z 2015 5 2015-05-01T04:00:00Z   2015-05-01T14:31:21Z   0 0 0900006481a6df2d
FDA-2008-N-0474-0032 FDA None FDA-2008-N-0474 Response from FDA CDER to L'Oreal USA Products Inc Other Response(s) 2015-05-01T04:00:00Z 2015 5 2015-05-01T04:00:00Z   2015-05-01T16:54:55Z   0 0 0900006481ac7a72
FDA-2008-N-0474-0024 FDA None FDA-2008-N-0474 Reference 6 - International Conference on Harmonization (ICH), Guidance for Industry, The Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals S1A, March 1996 Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T16:00:53Z   0 0 0900006481a113a5
FDA-2008-N-0474-0019 FDA None FDA-2008-N-0474 Reference 1 - FDA, Guidance for Industry, Photosafety Testing, May 2003 Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T15:59:35Z   0 0 0900006481a113a0
FDA-2008-N-0474-0028 FDA None FDA-2008-N-0474 Reference 10 - International Conference on Harmonization (ICH) Guideline for Industry, Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies S3A, March 1995 Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T16:01:35Z   0 0 0900006481a113b5
FDA-2008-N-0474-0022 FDA None FDA-2008-N-0474 Reference 4 - Schmidt et al, Photoallergic Contact Dermatitis Due to Combined UVB (4-Methylbenzylidene Camphor/Octyl Methoxycinnamate) and UVA (Benzophenone-3/Butyl Methoxydibenzoylmethane) Absorber Sensitization Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T16:00:22Z   0 0 0900006481a113a3
FDA-2008-N-0474-0018 FDA None FDA-2008-N-0474 Over-the-Counter Sunscreen Drug Products—Regulatory Status of Ecamsule Proposed Rule Notice of Proposed Rulemaking (NPRM) 2015-02-25T05:00:00Z 2015 2 2015-02-25T05:00:00Z 2015-04-14T03:59:59Z 2015-05-02T02:02:23Z 2015-03883 0 0 0900006481a16312
FDA-2008-N-0474-0020 FDA None FDA-2008-N-0474 Reference 2 - Leonard et al, The New Standard Battery of Photopatch Test in France. Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T16:00:03Z   0 0 0900006481a113a1
FDA-2008-N-0474-0027 FDA None FDA-2008-N-0474 Reference 9 - International Conference on Harmonization (ICH) Harmonized Tripartite Guideline for Industry Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility S5(R2), 2005 Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T16:01:25Z   0 0 0900006481a113b4
FDA-2008-N-0474-0021 FDA None FDA-2008-N-0474 Reference 3 - Schauder et al, Contact and Photocontact Sensitivity to Sunscreens. Review of a 15-Year Experience and of the Literature Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T16:00:12Z   0 0 0900006481a113a2
FDA-2008-N-0474-0023 FDA None FDA-2008-N-0474 Reference 5 - FDA Guidance for Industry, Guideline for the Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application, February 1987 Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T16:00:39Z   0 0 0900006481a113a4
FDA-2008-N-0474-0026 FDA None FDA-2008-N-0474 Reference 8 - International Conference on Harmonization (ICH) Guidance for Industry - S1C(R2) Dose Selection for Carcinogenicity Studies (Revision 1), September 2008 Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T16:01:16Z   0 0 0900006481a113a7
FDA-2008-N-0474-0025 FDA None FDA-2008-N-0474 Reference 7 - International Conference on Harmonization (ICH) Guidance for Industry, S1B Testing for Carcinogenicity of Pharmaceuticals, July 1997 Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T16:01:04Z   0 0 0900006481a113a6
FDA-2008-N-0474-0015 FDA None FDA-2008-N-0474 Volume 9 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006 Supporting & Related Material Background Material 2015-02-19T05:00:00Z 2015 2     2015-02-19T14:35:33Z   0 0 0900006481a093e5
FDA-2008-N-0474-0010 FDA None FDA-2008-N-0474 Volume 4 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006 Supporting & Related Material Background Material 2015-02-19T05:00:00Z 2015 2     2015-02-19T13:43:58Z   0 0 0900006481a093e0
FDA-2008-N-0474-0016 FDA None FDA-2008-N-0474 Volume 10 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006 Supporting & Related Material Background Material 2015-02-19T05:00:00Z 2015 2     2015-02-19T14:39:32Z   0 0 0900006481a09458
FDA-2008-N-0474-0009 FDA None FDA-2008-N-0474 Volume 3 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006 Supporting & Related Material Background Material 2015-02-19T05:00:00Z 2015 2     2015-02-19T13:43:51Z   0 0 0900006481a093df
FDA-2008-N-0474-0008 FDA None FDA-2008-N-0474 Volume 2 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006 Supporting & Related Material Background Material 2015-02-19T05:00:00Z 2015 2     2015-02-19T13:43:42Z   0 0 0900006481a093de
FDA-2008-N-0474-0013 FDA None FDA-2008-N-0474 Volume 7 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006 Supporting & Related Material Background Material 2015-02-19T05:00:00Z 2015 2     2015-02-19T14:07:52Z   0 0 0900006481a093e3
FDA-2008-N-0474-0012 FDA None FDA-2008-N-0474 Volume 6 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006 Supporting & Related Material Background Material 2015-02-19T05:00:00Z 2015 2     2015-02-19T13:57:17Z   0 0 0900006481a093e2
FDA-2008-N-0474-0011 FDA None FDA-2008-N-0474 Volume 5 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006 Supporting & Related Material Background Material 2015-02-19T05:00:00Z 2015 2     2015-02-19T13:49:38Z   0 0 0900006481a093e1
FDA-2008-N-0474-0017 FDA None FDA-2008-N-0474 Volume 11 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006 Supporting & Related Material Background Material 2015-02-19T05:00:00Z 2015 2     2015-02-19T15:10:39Z   0 0 0900006481a09459
FDA-2008-N-0474-0014 FDA None FDA-2008-N-0474 Volume 8 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006 Supporting & Related Material Background Material 2015-02-19T05:00:00Z 2015 2     2015-02-19T14:15:05Z   0 0 0900006481a093e4
FDA-2008-N-0474-0007 FDA None FDA-2008-N-0474 Volume 1 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006 Supporting & Related Material Background Material 2015-02-19T05:00:00Z 2015 2     2015-02-19T13:17:08Z   0 0 0900006481a093dd

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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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