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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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37 rows where docket_id = "FDA-1978-N-0018" and posted_year = 2015 sorted by posted_date descending

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  • 2015 · 37 ✖

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1978-N-0018-0807 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Attachments 1, 2 and 4 re: Supplement from Merck KGaA Supporting & Related Material Background Material 2015-03-30T04:00:00Z 2015 3     2019-08-09T14:13:22Z   0 0 090000648055a66e
FDA-1978-N-0018-0806 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Letter from Personal Care Products Council and Consumer Healthcare Products Association to FDA CDER Other Letter(s) 2015-03-20T04:00:00Z 2015 3 2015-03-20T04:00:00Z   2015-03-20T16:22:32Z   0 0 0900006481a549c3
FDA-1978-N-0018-0802 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Reference 27 - Guidance for Industry, S1B Testing for Carcinogenicity of Pharmaceuticals, July 1997 re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T17:37:21Z   0 0 0900006481a1130c
FDA-1978-N-0018-0805 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Reference 30 - International Conference on Harmonization (ICH) Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies S3A, March 1995 re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T17:37:50Z   0 0 0900006481a11044
FDA-1978-N-0018-0788 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Reference 13 - Schreurs et al, Estrogenic Activity of UV Filters Determined by an In Vitro Reporter Gene Assay and an In Vivo Transgenic Zebrafish Assay re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T17:35:02Z   0 0 0900006481a112c8
FDA-1978-N-0018-0794 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Reference 19 - Faas et al, Female Sexual Behavior, Estrous Cycle and Gene Expression in Sexually Dimorphic Brain Regions After Pre- and Postnatal Exposure to Endocrine Active UV Filters re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T17:36:03Z   0 0 0900006481a112ce
FDA-1978-N-0018-0775 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Proposed Rule Notice of Proposed Rulemaking (NPRM) 2015-02-25T05:00:00Z 2015 2 2015-02-25T05:00:00Z 2015-04-14T03:59:59Z 2015-04-14T02:11:05Z 2015-03884 0 0 0900006481a1641f
FDA-1978-N-0018-0780 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Reference 5 - Janjua et al, Sunscreens in Human Plasma and Urine After Repeated Whole-Body Topical Application re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T17:33:45Z   0 0 0900006481a10e87
FDA-1978-N-0018-0785 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Reference 10 - Mueller et al, Activation of Estrogen Receptor Alpha and ERbeta by 4-Methylbenzylidene-Camphor in Human and Rat Cells: Comparison With Phyto- and Xenoestrogens re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T17:34:35Z   0 0 0900006481a112c5
FDA-1978-N-0018-0795 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Reference 20 - Hofkamp et al, Region-Specific Growth Effects in the Developing Rat Prostate Following Fetal Exposure to Estrogenic Ultraviolet Filters re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T17:36:12Z   0 0 0900006481a11305
FDA-1978-N-0018-0797 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Reference 22 - Maerkel et al, Sex- and Region-Specific Alterations of Progesterone Receptor mRNA Levels and Estrogen Sensitivity in Rat Brain Following Developmental Exposure to the Estrogenic UV Filter 4-Methylbenzylidene Camphor re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T17:36:36Z   0 0 0900006481a11307
FDA-1978-N-0018-0798 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Reference 23 - Schlumpf et al, In Vitro and In Vivo Estrogenicity of UV Screens re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T17:36:47Z   0 0 0900006481a11308
FDA-1978-N-0018-0790 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Reference 15 - Soeborg et al, Risk Assessment of Topically Applied Products re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T17:35:20Z   0 0 0900006481a112ca
FDA-1978-N-0018-0804 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Reference 29 - 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 re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T17:37:41Z   0 0 0900006481a1130e
FDA-1978-N-0018-0779 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Reference 4 - Schauer, et al, Kinetics of 3-(methylbenzlidene) Camphor in Rats and Humans After Dermal Application re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T17:33:38Z   0 0 0900006481a10e86
FDA-1978-N-0018-0777 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Reference 2 - FDA, Guidance for Industry, Guideline for the Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application, February 1987 re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T17:33:22Z   0 0 0900006481a10e84
FDA-1978-N-0018-0778 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Reference 3 - Janjua, et al Systemic Absorption of the Sunscreens Benzophenone-3, Octyl-Methoxycinnamate, and 3-(4-Methyl-Benzylidene) Camphor After Whole Body Topical Application and Reproductive Hormone Levels in Humans re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T17:33:30Z   0 0 0900006481a10e85
FDA-1978-N-0018-0787 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Reference 12 - Schmutzler et al, Endocrine Disruptors and the Thyroid Gland-A Combined In Vitro and In Vivo Analysis of Potential New Biomarkers re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T17:34:54Z   0 0 0900006481a112c7
FDA-1978-N-0018-0796 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Reference 21 - Maerkel et al, Sexually Dimorphic Gene Regulation in Brain as a Target for Endocrine Disrupters: Developmental Exposure of Rats to 4-Methylbenzylidene Camphor re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T17:36:27Z   0 0 0900006481a11306
FDA-1978-N-0018-0786 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Reference 11 - Schlumpf et al, Estrogenic Activity and Estrogen Receptor Beta Binding of the UV Filter 3-Benzylidene Camphor. Comparison With 4-Methylbenzylidene Camphor re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T17:34:46Z   0 0 0900006481a112c6
FDA-1978-N-0018-0783 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Reference 8 - Gomez et al, Estrogenic Activity of Cosmetic Components in Reporter Cell Lines: Parabens, UV Screens and Musks re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T17:34:16Z   0 0 0900006481a10e8a
FDA-1978-N-0018-0784 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Reference 9 - Ma et al, UV Filters With Antagonistic Action at Androgen Receptors in the MDA-kb2 Cell Transcriptional-Activation Assay re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T17:34:26Z   0 0 0900006481a10e8b
FDA-1978-N-0018-0791 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Reference 16 -Tinwell et al, Confirmation of Uterotrophic Activity of 3-(4-Methylbenzylidine) Camphor in the Immature Rat re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T17:35:32Z   0 0 0900006481a112cb
FDA-1978-N-0018-0799 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Reference 24 - Schlumpf et al, Estrogenic Activity and Estrogen Receptor Beta Binding of the UV Filter 3-Benzylidene Camphor. Comparison With 4-Methylbenzylidene Camphor re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T17:36:57Z   0 0 0900006481a11309
FDA-1978-N-0018-0801 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Reference 26 - International Conference on Harmonization (ICH), Guidance for Industry, The Need for Long Term Rodent Carcinogenicity Studies of Pharmaceuticals S1A, March 1996 re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T17:37:14Z   0 0 0900006481a1130b
FDA-1978-N-0018-0803 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Reference 28 - International Conference on Harmonization (ICH) Guidance for Industry - S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals SIC(R2) (Revision 1), September 2008 re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T17:37:33Z   0 0 0900006481a1130d
FDA-1978-N-0018-0781 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Reference 6 - Scientific Committee on Consumer Products (SCCP)/1184/08-SCCNFP Opinion on 4-Methylbenzylidene Camphor (4-MBC) Colipa n° S60 Adopted During the 16th Plenary Meeting of June 24, 2008 re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T17:33:55Z   0 0 0900006481a10e88
FDA-1978-N-0018-0782 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Reference 7- Jimenez-Diaz et al, Simultaneous Determination of the UV-Filters Benzyl Salicylate, Phenyl Salicylate, Octyl Salicylate, Homosalate, 3-(4-Methylbenzylidene) Camphor and 3-Benzylidene Camphor in Human Placental Tissue by LC-MS/MS. Assessment of Their In Vitro Endocrine Activity re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T17:34:05Z   0 0 0900006481a10e89
FDA-1978-N-0018-0789 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Reference 14 - Seidlova Wuttke et al, Comparison of Effects of Estradiol With Those of Octylmethoxycinnamate and 4-Methylbenzylidene Camphor on Fat Tissue, Lipids and Pituitary Hormones re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T17:35:12Z   0 0 0900006481a112c9
FDA-1978-N-0018-0776 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Reference 1 - FDA, Guidance for industry, Photosafety Testing, May 2003 re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T17:33:10Z   0 0 0900006481a10e83
FDA-1978-N-0018-0792 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Reference 17 - Durrer et al, Estrogen Sensitivity of Target Genes and Expression of Nuclear Receptor Co-Regulators in Rat Prostate After Pre- and Postnatal Exposure to the Ultraviolet Filter 4-Methylbenzylidene Camphor re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T17:35:41Z   0 0 0900006481a112cc
FDA-1978-N-0018-0793 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Reference 18 - Durrer et al, Estrogen Target Gene Regulation and Coactivator Expression in Rat Uterus After Developmental Exposure to the Ultraviolet Filter 4-Methylbenzylidene Camphor re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T17:35:52Z   0 0 0900006481a112cd
FDA-1978-N-0018-0800 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Reference 25 - Schlumpf et al, Endocrine Activity and Developmental Toxicity of Cosmetic UV Filters-An Update re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene Supporting & Related Material Background Material 2015-02-25T05:00:00Z 2015 2     2015-02-25T17:37:05Z   0 0 0900006481a1130a
FDA-1978-N-0018-0774 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Slide Presentation from the Sunscreen Innovation Act Stakeholder Meeting re Meeting Announcement from FDA CDER re FDA Implementation of the Sunscreen Innovation Act (SIA), February 4 2015, FDA-1978-N-0018-0772 Supporting & Related Material Meeting Materials 2015-02-23T05:00:00Z 2015 2     2015-02-24T04:43:32Z   0 0 0900006481a10372
FDA-1978-N-0018-0773 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Summary of Meeting re Meeting Announcement from FDA CDER re FDA Implementation of the Sunscreen Innovation Act SIA February 4 2015, FDA-1978-N-0018-0772 Supporting & Related Material Meeting Summary 2015-02-23T05:00:00Z 2015 2     2015-02-24T04:44:20Z   0 0 0900006481a1036f
FDA-1978-N-0018-0772 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Meeting Announcement from FDA CDER re FDA Implementation of the Sunscreen Innovation Act (SIA), February 4 2015 Other Memorandum 2015-01-26T05:00:00Z 2015 1 2015-01-26T05:00:00Z   2015-02-24T04:46:31Z   0 0 09000064819e06e0
FDA-1978-N-0018-0771 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Letter from The Proprietary Association to FDA Other Letter(s) 2015-01-05T05:00:00Z 2015 1     2019-08-09T17:54:57Z   0 0 09000064805596c4

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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);