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

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146 rows where docket_id = "FDA-1996-N-0006" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1996-N-0006-0193 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Meeting Request from Environmental Working Group Other Letter(s) 2020-01-15T05:00:00Z 2020 1 2020-01-15T05:00:00Z   2020-01-15T21:48:05Z   0 0 09000064842ac71f
FDA-1996-N-0006-0191 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 PASS Coalition and FDA Meeting Minutes_November 1 2016 Other Minutes 2020-01-15T05:00:00Z 2020 1 2020-01-15T05:00:00Z   2020-01-15T21:33:01Z   0 0 09000064842ac515
FDA-1996-N-0006-0194 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Meeting Minutes for Meeting between EWG and FDA Other Letter(s) 2020-01-15T05:00:00Z 2020 1 2020-01-15T05:00:00Z   2020-01-15T21:49:43Z   0 0 09000064842ac721
FDA-1996-N-0006-0192 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA CDER for Announcement of Meeting with PASS Coalition_ Other Letter(s) 2020-01-15T05:00:00Z 2020 1 2020-01-15T05:00:00Z   2020-01-15T21:35:50Z   0 0 09000064842ac517
FDA-1996-N-0006-0190 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA CDER for Announcement of Meeting with PASS Coalition Other Letter(s) 2016-10-21T04:00:00Z 2016 10 2016-10-21T04:00:00Z   2016-10-21T14:20:00Z   0 0 0900006482330e55
FDA-1996-N-0006-0189 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA CDER for Announcement of Meeting Other Letter(s) 2016-10-07T04:00:00Z 2016 10 2016-10-07T04:00:00Z   2016-10-07T12:01:15Z   0 0 09000064822a11d4
FDA-1996-N-0006-0188 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Background Material Specific Questions for FDA from Holland&Knight Supporting & Related Material Background Material 2016-09-15T04:00:00Z 2016 9     2016-09-15T19:29:20Z   0 0 090000648221463d
FDA-1996-N-0006-0187 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Request for Meeting from PASS Coalition (Holland & Knight) Other Request 2016-09-08T04:00:00Z 2016 9 2016-09-08T04:00:00Z   2016-09-08T18:14:49Z   0 0 09000064821e3bb9
FDA-1996-N-0006-0183 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from Environmental Working Group to FDA DDM, FDA CDER Other Letter(s) 2016-08-29T04:00:00Z 2016 8 2016-08-29T04:00:00Z   2016-08-29T15:56:47Z   0 0 09000064821a94be
FDA-1996-N-0006-0185 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Attachment 2 EWG's 2016 Sunscreen Guide (2016), http://www.ewg.org/sunscreen re: Letter from Environmental Working Group to FDA DDM, FDA CDER Supporting & Related Material Background Material 2016-08-29T04:00:00Z 2016 8     2016-08-29T16:01:59Z   0 0 09000064821a962a
FDA-1996-N-0006-0186 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Attachment 3 EWG analysis of labeled SPF and in vitro measured SPF from Nash 2009 Market Survey Data re: Letter from Environmental Working Group to FDA DDM, FDA CDER Supporting & Related Material Background Material 2016-08-29T04:00:00Z 2016 8     2016-08-29T16:05:02Z   0 0 09000064821a962b
FDA-1996-N-0006-0184 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Attachment 1 Letter from Ken Cook, et al., EWG to Robert M. Califf, MD, Commissioner, FDA (Aug. 18, 2016) re: Letter from Environmental Working Group to FDA DDM, FDA CDER Supporting & Related Material Background Material 2016-08-29T04:00:00Z 2016 8     2016-08-29T15:59:37Z   0 0 09000064821a9629
FDA-1996-N-0006-0176 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Reference 9 CP1, 81N-0033 re Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Supporting & Related Material Background Material 2015-07-07T04:00:00Z 2015 7     2015-07-07T20:27:50Z   0 0 09000064804f9942
FDA-1996-N-0006-0177 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Attachment 5 Conference Report re Comment from Merck KGaA Supporting & Related Material Background Material 2015-07-07T04:00:00Z 2015 7     2015-07-07T20:27:50Z   0 0 09000064804f9955
FDA-1996-N-0006-0178 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Attachment 4 Review Of Over The Counter Active Ingredients re Comment from Merck KGaA Supporting & Related Material Background Material 2015-07-07T04:00:00Z 2015 7     2015-07-07T20:27:50Z   0 0 09000064804f9956
FDA-1996-N-0006-0180 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Attachment 3 American Academy Of Dermatology, Sun Protection re Comment from Merck KGaA Supporting & Related Material Background Material 2015-07-07T04:00:00Z 2015 7     2015-07-07T20:27:50Z   0 0 09000064804f9958
FDA-1996-N-0006-0179 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Attachment 3 Ostroff, The Bottom Line On ASIA re Comment from Merck KGaA Supporting & Related Material Background Material 2015-07-07T04:00:00Z 2015 7     2015-07-07T20:27:50Z   0 0 09000064804f9957
FDA-1996-N-0006-0167 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Reference 4 CP1, 78N-0038 re Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Supporting & Related Material Background Material 2015-07-07T04:00:00Z 2015 7     2015-07-07T20:27:48Z   0 0 09000064804f9939
FDA-1996-N-0006-0168 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Reference 5 CP2, 78N-0038 re Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Supporting & Related Material Background Material 2015-07-07T04:00:00Z 2015 7     2015-07-07T20:27:49Z   0 0 09000064804f993a
FDA-1996-N-0006-0166 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 List of References re Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System Supporting & Related Material Background Material 2015-07-07T04:00:00Z 2015 7     2015-07-07T20:27:48Z   0 0 09000064804f9938
FDA-1996-N-0006-0170 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Reference 13 CP1, 95P-0145 re Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Supporting & Related Material Background Material 2015-07-07T04:00:00Z 2015 7     2015-07-07T20:27:49Z   0 0 09000064804f993c
FDA-1996-N-0006-0175 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Reference 8 C105, 78N-0038 re Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Supporting & Related Material Background Material 2015-07-07T04:00:00Z 2015 7     2015-07-07T20:27:49Z   0 0 09000064804f9941
FDA-1996-N-0006-0165 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Reference 1 PDN2, 77N-0094 re Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System Supporting & Related Material Background Material 2015-07-07T04:00:00Z 2015 7     2015-07-07T20:27:48Z   0 0 09000064804f9937
FDA-1996-N-0006-0163 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Reference 3 Letter from Thomas Scarlett re Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System Supporting & Related Material Background Material 2015-07-07T04:00:00Z 2015 7     2015-07-07T20:27:48Z   0 0 09000064804f9935
FDA-1996-N-0006-0173 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Reference 10 CP1, 92P-0309 re Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Supporting & Related Material Background Material 2015-07-07T04:00:00Z 2015 7     2015-07-07T20:27:49Z   0 0 09000064804f993f
FDA-1996-N-0006-0161 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Request for Extension from Merck KGaA & U.S. EM Industries, Inc. Other Request for Extension 2015-07-07T04:00:00Z 2015 7 2015-07-07T04:00:00Z   2015-07-07T20:25:46Z   0 0 09000064804f9965
FDA-1996-N-0006-0174 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Reference 7 CP4, 78N-0308 re Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Supporting & Related Material Background Material 2015-07-07T04:00:00Z 2015 7     2015-07-07T20:27:49Z   0 0 09000064804f9940
FDA-1996-N-0006-0172 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Reference 11 CP1, 94P-0215 re Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Supporting & Related Material Background Material 2015-07-07T04:00:00Z 2015 7     2015-07-07T20:27:49Z   0 0 09000064804f993e
FDA-1996-N-0006-0171 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Reference 12 CP2, 94P-0215 re Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Supporting & Related Material Background Material 2015-07-07T04:00:00Z 2015 7     2015-07-07T20:27:49Z   0 0 09000064804f993d
FDA-1996-N-0006-0182 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 OMB Revisions of the final Rule re Additional Criteria and Procedures for Classifying OTC Drugs as Generally Recognized as Safe and Effective and not Misbranded Supporting & Related Material Reference (internal unless indicated) 2015-07-07T04:00:00Z 2015 7     2015-07-07T20:27:50Z   0 0 09000064804f9979
FDA-1996-N-0006-0164 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Reference 2 Let95, 78N-0038 re Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System Supporting & Related Material Background Material 2015-07-07T04:00:00Z 2015 7     2015-07-07T20:27:48Z   0 0 09000064804f9936
FDA-1996-N-0006-0181 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Attachment 1 Letter of Authorization re Comment from Merck KGaA Supporting & Related Material Background Material 2015-07-07T04:00:00Z 2015 7     2015-07-07T20:27:50Z   0 0 09000064804f9959
FDA-1996-N-0006-0169 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Reference 6 CP3, 78N-0038 re Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Supporting & Related Material Background Material 2015-07-07T04:00:00Z 2015 7     2015-07-07T20:27:49Z   0 0 09000064804f993b
FDA-1996-N-0006-0131 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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   2015-05-05T20:05:57Z   0 0 0900006481a548dc
FDA-1996-N-0006-0119 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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     2015-06-22T15:14:46Z   0 0 0900006481a11365
FDA-1996-N-0006-0124 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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     2015-06-22T15:26:23Z   0 0 0900006481a1137b
FDA-1996-N-0006-0101 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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     2015-06-22T14:09:48Z   0 0 0900006481a11045
FDA-1996-N-0006-0130 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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     2015-06-22T15:58:34Z   0 0 0900006481a1139e
FDA-1996-N-0006-0104 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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     2015-06-22T14:26:52Z   0 0 0900006481a1104b
FDA-1996-N-0006-0120 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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     2015-06-22T15:16:09Z   0 0 0900006481a11373
FDA-1996-N-0006-0127 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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     2015-06-22T15:36:17Z   0 0 0900006481a1138b
FDA-1996-N-0006-0100 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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 2015-02-25T17:40:37Z 2015-03884 0 0 0900006481a16b78
FDA-1996-N-0006-0128 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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     2015-06-22T15:38:44Z   0 0 0900006481a1138d
FDA-1996-N-0006-0113 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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     2015-06-22T14:51:58Z   0 0 0900006481a11349
FDA-1996-N-0006-0123 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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     2015-06-22T15:22:10Z   0 0 0900006481a11379
FDA-1996-N-0006-0129 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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     2015-06-22T15:51:28Z   0 0 0900006481a1138f
FDA-1996-N-0006-0102 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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     2015-06-22T14:20:03Z   0 0 0900006481a11047
FDA-1996-N-0006-0103 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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     2015-06-22T14:22:03Z   0 0 0900006481a11049
FDA-1996-N-0006-0107 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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     2015-06-22T14:41:11Z   0 0 0900006481a11332
FDA-1996-N-0006-0109 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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     2015-06-22T14:46:34Z   0 0 0900006481a11337
FDA-1996-N-0006-0112 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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     2015-06-22T14:50:16Z   0 0 0900006481a11347
FDA-1996-N-0006-0115 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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     2015-06-22T14:59:57Z   0 0 0900006481a1135d
FDA-1996-N-0006-0126 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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     2015-06-22T15:31:30Z   0 0 0900006481a11389
FDA-1996-N-0006-0114 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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     2015-06-22T14:56:40Z   0 0 0900006481a1134b
FDA-1996-N-0006-0122 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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     2015-06-22T15:21:22Z   0 0 0900006481a11377
FDA-1996-N-0006-0117 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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     2015-06-22T15:09:41Z   0 0 0900006481a11361
FDA-1996-N-0006-0121 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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     2015-06-22T15:19:32Z   0 0 0900006481a11375
FDA-1996-N-0006-0105 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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     2015-06-22T14:30:38Z   0 0 0900006481a1104d
FDA-1996-N-0006-0106 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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     2015-06-22T14:37:31Z   0 0 0900006481a11330
FDA-1996-N-0006-0110 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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     2015-06-22T14:47:50Z   0 0 0900006481a11343
FDA-1996-N-0006-0125 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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     2015-06-22T15:27:47Z   0 0 0900006481a11387
FDA-1996-N-0006-0108 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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     2015-06-22T14:46:11Z   0 0 0900006481a11335
FDA-1996-N-0006-0116 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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     2015-06-22T15:03:10Z   0 0 0900006481a1135f
FDA-1996-N-0006-0118 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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     2015-06-22T15:10:46Z   0 0 0900006481a11363
FDA-1996-N-0006-0111 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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     2015-06-22T14:48:48Z   0 0 0900006481a11345
FDA-1996-N-0006-0098 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Summary of Meeting Announcement from FDA CDER re FDA Implementation of the Sunscreen Innovation Act SIA February 4 2015, FDA-1996-N-0006-0097 Supporting & Related Material Meeting Summary 2015-02-23T05:00:00Z 2015 2     2015-05-13T13:55:57Z   0 0 0900006481a103e1
FDA-1996-N-0006-0099 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Slide Presentatition from the Sunscreen Innovation Act Stakeholder Meeting re FDA Implementation of the Sunscreen Innovation Act SIA February 4 2015, FDA-1996-N-0006-0097 Supporting & Related Material Meeting Materials 2015-02-23T05:00:00Z 2015 2     2015-02-23T22:19:50Z   0 0 0900006481a1078d
FDA-1996-N-0006-0097 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 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   2015-05-05T20:00:27Z   0 0 09000064819e06e2
FDA-1996-N-0006-0089 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Information from L'Oreal USA Products, Inc. re FDA-1996-N-0006-0087 Supporting & Related Material   2010-05-10T00:00:00Z 2010 5     2015-03-20T18:06:23Z   0 1 0900006480ad4912
FDA-1996-N-0006-0079 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Safety and Efficacy Review for Additional Ingredients in Over-the-Counter Drug Products for Human Use; Request for Environmental Impact Data and Information Notice NRD-Notice of Requesting Data, Info, & Views 2010-02-22T05:00:00Z 2010 2 2010-02-22T05:00:00Z 2010-05-25T03:59:59Z 2010-04-19T22:24:26Z 2010-03319 0 0 0900006480aa9b56
FDA-1996-N-0006-0078 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Memorandum of Meeting Minutes from May 14, 2009 Other MM-Memorandum of Meeting 2010-01-04T05:00:00Z 2010 1 2010-01-04T05:00:00Z   2015-05-05T19:29:53Z   0 0 0900006480a75f9b
FDA-1996-N-0006-0067 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER Division of Nonprescription Regulation Development to Keller and Heckman, LLP, May 4, 2009 Other Letter(s) 2009-05-05T04:00:00Z 2009 5 2009-05-05T04:00:00Z   2015-05-05T18:56:47Z   0 0 0900006480975db3
FDA-1996-N-0006-0076 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER Division of Nonprescription Regulation Development to Buchanan Ingersoll, May 4, 2009 Other Letter(s) 2009-05-05T04:00:00Z 2009 5 2009-05-05T04:00:00Z   2015-05-05T19:26:22Z   0 0 090000648097603e
FDA-1996-N-0006-0070 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER Division of Nonprescription Regulation Development to Morgan, Lewis & Bockius, LLP, May 4, 2009 Other Letter(s) 2009-05-05T04:00:00Z 2009 5 2009-05-05T04:00:00Z   2015-05-05T19:09:46Z   0 0 0900006480976038
FDA-1996-N-0006-0065 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER Division of Nonprescription Regulation Development to Steinberg & Associates, Inc., May 4, 2009 Other Letter(s) 2009-05-05T04:00:00Z 2009 5 2009-05-05T04:00:00Z   2015-05-05T18:48:08Z   0 0 0900006480975db0
FDA-1996-N-0006-0068 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER Division of Nonprescription Regulation Development to The Personal Care Products Council, May 4, 2009 Other Letter(s) 2009-05-05T04:00:00Z 2009 5 2009-05-05T04:00:00Z   2015-05-05T18:59:39Z   0 0 0900006480975db4
FDA-1996-N-0006-0075 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter From FDA/CDER Division of Nonprescription Regulation Development to Dow Pharmaceutical Sciences, May 4, 2009 Other Letter(s) 2009-05-05T04:00:00Z 2009 5 2009-05-05T04:00:00Z   2015-05-05T19:24:17Z   0 0 090000648097603d
FDA-1996-N-0006-0077 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER Division of Nonprescription Regulation Development to RJR Consulting, Inc., May 4, 2009 Other Letter(s) 2009-05-05T04:00:00Z 2009 5 2009-05-05T04:00:00Z   2015-05-05T19:28:13Z   0 0 090000648097603f
FDA-1996-N-0006-0071 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER Division of Nonprescription Regulation Development to 3V, Inc., May 4, 2009 Other Letter(s) 2009-05-05T04:00:00Z 2009 5 2009-05-05T04:00:00Z   2015-05-05T19:13:03Z   0 0 0900006480976039
FDA-1996-N-0006-0072 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER Division of Nonprescription Regulation Development to CIBA Specialty Chemicals Corporation, May 4, 2009 Other Letter(s) 2009-05-05T04:00:00Z 2009 5 2009-05-05T04:00:00Z   2015-05-05T19:16:57Z   0 0 090000648097603a
FDA-1996-N-0006-0069 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER Division of Nonprescription Regulation Development to L'Oreal USA Products R&D, May 4, 2009 Other Letter(s) 2009-05-05T04:00:00Z 2009 5 2009-05-05T04:00:00Z   2015-05-05T19:05:01Z   0 0 0900006480976037
FDA-1996-N-0006-0073 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER Division of Nonprescription Regulation Development to Consumer Healthcare Products Association (CHPA), May 4, 2009 Other Letter(s) 2009-05-05T04:00:00Z 2009 5 2009-05-05T04:00:00Z   2015-05-05T19:20:57Z   0 0 090000648097603b
FDA-1996-N-0006-0066 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER Division of Nonprescription Regulation Development to Ropes & Gray, LLP, May 4, 2009 Other Letter(s) 2009-05-05T04:00:00Z 2009 5 2009-05-05T04:00:00Z   2015-05-05T18:53:34Z   0 0 0900006480975db2
FDA-1996-N-0006-0074 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER Division of Nonprescription Regulation Development to Parexel International, May 4, 2009 Other Letter(s) 2009-05-05T04:00:00Z 2009 5 2009-05-05T04:00:00Z   2015-05-05T19:22:46Z   0 0 090000648097603c
FDA-1996-N-0006-0058 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER Division of Nonprescription Regulation Development to Morgan, Lewis & Bockius, LLP Other Letter(s) 2009-04-16T04:00:00Z 2009 4 2009-04-16T04:00:00Z   2015-05-05T18:41:16Z   0 0 090000648095735a
FDA-1996-N-0006-0055 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER Division of Nonprescription Regulation Development to CIBA Specialty Chemicals Corporation Other Letter(s) 2009-04-16T04:00:00Z 2009 4 2009-04-16T04:00:00Z   2015-05-05T18:36:15Z   0 0 090000648095725e
FDA-1996-N-0006-0056 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER Division of Nonprescription Regulation Development to Buchanan Ingersoll Other Letter(s) 2009-04-16T04:00:00Z 2009 4 2009-04-16T04:00:00Z   2015-05-05T18:38:09Z   0 0 0900006480957293
FDA-1996-N-0006-0052 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER Division of Nonprescription Regulation Development to 3V, Inc. Other Letter(s) 2009-04-16T04:00:00Z 2009 4 2009-04-16T04:00:00Z   2015-05-05T18:30:48Z   0 0 09000064809571c2
FDA-1996-N-0006-0062 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from Steinberg & Associates, Inc. to FDA/CDER Questions Other Letter(s) 2009-04-16T04:00:00Z 2009 4 2009-04-16T04:00:00Z   2015-05-05T18:03:20Z   0 0 0900006480957545
FDA-1996-N-0006-0051 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER Division of Nonprescription Regulation Development to Parexel International Other Letter(s) 2009-04-16T04:00:00Z 2009 4 2009-04-16T04:00:00Z   2015-05-05T18:28:40Z   0 0 0900006480957156
FDA-1996-N-0006-0049 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER Division of Nonprescription Regulation Development to The Personal Care Products Council Other Letter(s) 2009-04-16T04:00:00Z 2009 4 2009-04-16T04:00:00Z   2015-05-05T18:24:11Z   0 0 0900006480956ede
FDA-1996-N-0006-0061 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER Division of Nonprescription Regulation Development to Steinberg & Associates, Inc. Other Letter(s) 2009-04-16T04:00:00Z 2009 4 2009-04-16T04:00:00Z   2015-05-05T18:46:23Z   0 0 090000648095744d
FDA-1996-N-0006-0053 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER Division of Nonprescription Regulation Development to Dow Pharmaceutical Sciences Other Letter(s) 2009-04-16T04:00:00Z 2009 4 2009-04-16T04:00:00Z   2015-05-05T18:32:36Z   0 0 0900006480957206
FDA-1996-N-0006-0059 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER Division of Nonprescription Regulation Development to Ropes & Gray, LLP Other Letter(s) 2009-04-16T04:00:00Z 2009 4 2009-04-16T04:00:00Z   2015-05-05T18:43:16Z   0 0 09000064809573e1
FDA-1996-N-0006-0057 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER Division of Nonprescription Regulation Development to L'Oreal USA Products R&D Other Letter(s) 2009-04-16T04:00:00Z 2009 4 2009-04-16T04:00:00Z   2015-05-05T18:39:36Z   0 0 09000064809572ff
FDA-1996-N-0006-0050 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER Division of Nonprescription Regulation Development to RJR Consulting, Inc. Other Letter(s) 2009-04-16T04:00:00Z 2009 4 2009-04-16T04:00:00Z   2015-05-05T18:26:52Z   0 0 0900006480956f1d
FDA-1996-N-0006-0054 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER Division of Nonprescription Regulation Development to Keller and Heckman, LLP Other Letter(s) 2009-04-16T04:00:00Z 2009 4 2009-04-16T04:00:00Z   2015-05-05T18:34:24Z   0 0 0900006480957233
FDA-1996-N-0006-0060 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER Division of Nonprescription Regulation Development to Consumer Healthcare Products Association (CHPA) Other Letter(s) 2009-04-16T04:00:00Z 2009 4 2009-04-16T04:00:00Z   2015-05-05T18:44:54Z   0 0 0900006480957423
FDA-1996-N-0006-0048 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER Additional Conditions in the Over-the-Counter Drug Monograph System - Time and Extent Application (TEA) Process; Request for Information and Questions; Extension of Deadline for Submissions Other Letter(s) 2009-04-16T04:00:00Z 2009 4 2009-04-16T04:00:00Z 2009-05-01T03:59:59Z 2015-05-05T18:21:11Z   0 0 0900006480954d7f
FDA-1996-N-0006-0041 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER Division of Nonprescription Regulation Development to Ropes & Gray, LLP Other Letter(s) 2009-04-14T04:00:00Z 2009 4 2009-04-14T04:00:00Z   2015-05-05T15:50:55Z   0 0 0900006480953826

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