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

11,812 rows where agency_id = "FDA" and posted_year = 2015 sorted by posted_date descending

✎ View and edit SQL

This data as json, CSV (advanced)

Suggested facets: withdrawn, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

document_type 5

posted_year 1

  • 2015 · 11,812 ✖

agency_id 1

  • FDA · 11,812 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2015-A-4705-0001 FDA FDA-2015-A-4705 Advisory Opinion Petition from Luedeka Neely Group, P.C. on behalf of Consorzio del Formaggio Parmigiano-Reggiano Other Advisory Opinion Petition 2015-12-31T05:00:00Z 2015 12 2015-12-31T05:00:00Z   2024-11-11T21:15:26Z   1 0 0900006481d93908
FDA-2015-P-5108-0002 FDA FDA-2015-P-5108 Acknowledgement Letter from FDA DDM to Kleinfeld, Kaplan and Becker, LLP Other Acknowledgement Letter/Receipt 2015-12-31T05:00:00Z 2015 12 2015-12-31T05:00:00Z   2015-12-31T19:22:42Z   0 0 0900006481ddf501
FDA-2014-E-0934-0004 FDA FDA-2014-E-0934 Letter from U.S. Patent and Trademark Office Other Letter(s) 2015-12-31T05:00:00Z 2015 12 2015-12-31T05:00:00Z   2015-12-31T16:10:23Z   0 0 0900006481ddf54c
FDA-2014-E-2349-0004 FDA FDA-2014-E-2349 Letter from U.S. Patent and Trademark Office Other Letter(s) 2015-12-31T05:00:00Z 2015 12 2015-12-31T05:00:00Z   2015-12-31T16:22:53Z   0 0 0900006481ddf550
FDA-2015-D-4803-0001 FDA FDA-2015-D-4803 Public Notification of Emerging Postmarket Medical Device Signals ("Emerging Signals''); Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2015-12-31T05:00:00Z 2015 12 2015-12-31T05:00:00Z 2016-03-01T04:59:59Z 2016-02-26T23:00:43Z 2015-32920 0 0 0900006481dde96a
FDA-2015-P-5108-0003 FDA FDA-2015-P-5108 Exhibit 1 Physicians Desk Reference, 53rd Ed. 1999 Label for Percodan re Citizen Petition from Purdue Pharma L.P. (Kleinfeld, Kaplan and Becker, LLP) Supporting & Related Material Background Material 2015-12-31T05:00:00Z 2015 12     2015-12-31T19:24:16Z   0 0 0900006481dd73d8
FDA-2015-F-0537-0023 FDA FDA-2015-F-0537 BASF Corp Appendix-D Spiking Validation at Low Perchlorate (Redacted) re: Supplemental Comments from BASF Corporation (Keller and Heckman LLP) Supporting & Related Material Background Material 2015-12-31T05:00:00Z 2015 12     2015-12-31T15:28:46Z   0 0 0900006481ddf21b
FDA-2015-E-5107-0001 FDA FDA-2015-E-5107 Patent Extension Application from Novo Nordisk A /S Other Application 2015-12-31T05:00:00Z 2015 12 2015-12-31T05:00:00Z   2015-12-31T15:57:59Z   0 0 0900006481ddf05f
FDA-2015-A-4705-0002 FDA FDA-2015-A-4705 Acknowledgement Letter from FDA DDM to Luedeka Neely Group, P.C. on behalf of Consorzio del Formaggio Parmigiano-Reggiano Other Acknowledgement Letter/Receipt 2015-12-31T05:00:00Z 2015 12 2015-12-31T05:00:00Z   2015-12-31T19:04:51Z   0 0 0900006481d93bc4
FDA-2015-P-5108-0009 FDA FDA-2015-P-5108 Exhibit 11 Benziger, Cheng, Miotto, and Grandy Comparative Pharmacokinetics of Controlled Release Oxycodone (OxyContin) in special populations re Citizen Petition from Purdue Pharma L.P. (Kleinfeld, Kaplan and Becker, LLP) Supporting & Related Material Background Material 2015-12-31T05:00:00Z 2015 12     2015-12-31T19:42:08Z   0 0 0900006481dd91ad
FDA-2015-P-5108-0004 FDA FDA-2015-P-5108 Exhibit 2 Physicians Desk Reference, 53rd Ed. 1999 Label for OxyContin re Citizen Petition from Purdue Pharma L.P. (Kleinfeld, Kaplan and Becker, LLP) Supporting & Related Material Background Material 2015-12-31T05:00:00Z 2015 12     2015-12-31T19:25:19Z   0 0 0900006481dd73d9
FDA-2015-P-5108-0005 FDA FDA-2015-P-5108 Exhibit 4 Medical Officer Review, Integrated Summary of Efficacy, Oxycodone Controlled Release, NDA 20553 and Medical officer Review, OxyContin Study 0402B-Cancer Pain re Citizen Petition from Purdue Pharma L.P. (Kleinfeld, Kaplan and Becker, LLP) Supporting & Related Material Background Material 2015-12-31T05:00:00Z 2015 12     2015-12-31T19:28:13Z   0 0 0900006481dd73db
FDA-2015-P-5108-0010 FDA FDA-2015-P-5108 Exhibit 12 Kaiko, Grandy, Hou, and Benziger Controlled Release Oxycodone Pharmacokinetics Pharmacodynamics in Hepatic Cirrhosis (Abstract) re Citizen Petition from Purdue Pharma L.P. (Kleinfeld, Kaplan and Becker, LLP) Supporting & Related Material Background Material 2015-12-31T05:00:00Z 2015 12     2015-12-31T19:47:34Z   0 0 0900006481dd91ae
FDA-2015-E-5107-0002 FDA FDA-2015-E-5107 Letter from U.S. Patent and Trademark Office Other Letter(s) 2015-12-31T05:00:00Z 2015 12 2015-12-31T05:00:00Z   2015-12-31T15:58:21Z   0 0 0900006481ddf0a8
FDA-2014-N-1207-2060 FDA FDA-2014-N-1207 Request for Extension from Institute of Food Technologists (IFT) Other Request for Extension 2015-12-31T05:00:00Z 2015 12 2015-12-31T05:00:00Z   2015-12-31T16:52:55Z   0 0 0900006481dbae86
FDA-2015-P-5108-0006 FDA FDA-2015-P-5108 Exhibit 5 Exclusivity Summary, NDA 20553 re Citizen Petition from Purdue Pharma L.P. (Kleinfeld, Kaplan and Becker, LLP) Supporting & Related Material Background Material 2015-12-31T05:00:00Z 2015 12     2015-12-31T19:29:45Z   0 0 0900006481dd7b86
FDA-2015-P-5081-0002 FDA FDA-2015-P-5081 Acknowledgement Letter from FDA DDM to O'Hara et al. Other Acknowledgement Letter/Receipt 2015-12-31T05:00:00Z 2015 12 2015-12-31T05:00:00Z   2015-12-31T16:31:28Z   0 0 0900006481dd9c0e
FDA-2015-F-0537-0020 FDA FDA-2015-F-0537 BASF Corp Appendix A Analysis Method (Redacted) re: Supplemental Comments from BASF Corporation (Keller and Heckman LLP) Supporting & Related Material Background Material 2015-12-31T05:00:00Z 2015 12     2015-12-31T15:21:02Z   0 0 0900006481ddeef1
FDA-2015-P-5081-0001 FDA FDA-2015-P-5081 Citizen Petiton from O'Hara, Vogel, Bazlen, Craig, Denning, Willson, Weir and Larock Other Citizen Petition 2015-12-31T05:00:00Z 2015 12 2015-12-31T05:00:00Z   2024-11-11T21:17:54Z   1 0 0900006481dd9c0b
FDA-2015-D-4803-0002 FDA FDA-2015-D-4803 Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”); Draft Guidance for Industry and Food and Drug Administration Staff Other Guidance 2015-12-31T05:00:00Z 2015 12 2015-12-31T05:00:00Z   2024-11-11T21:17:59Z   1 0 0900006481ddecf3
FDA-2015-P-1898-0004 FDA FDA-2015-P-1898 Letter from FDA CDER to Hyman, Phelps & McNamara PC Other Letter(s) 2015-12-31T05:00:00Z 2015 12 2015-12-31T05:00:00Z   2015-12-31T14:55:43Z   0 0 0900006481ddee16
FDA-2015-P-5108-0008 FDA FDA-2015-P-5108 Exhibit 9 Comments from Purdue Pharma L.P. Docket No. FDA-2011-N-0830 (June 8, 2015) re Citizen Petition from Purdue Pharma L.P. (Kleinfeld, Kaplan and Becker, LLP) Supporting & Related Material Background Material 2015-12-31T05:00:00Z 2015 12     2015-12-31T19:37:07Z   0 0 0900006481dd91ab
FDA-2015-F-0537-0019 FDA FDA-2015-F-0537 BASF Corp Migration Report (Redacted) re: Supplemental Comments from BASF Corporation (Keller and Heckman LLP) Supporting & Related Material Background Material 2015-12-31T05:00:00Z 2015 12     2015-12-31T15:18:34Z   0 0 0900006481ddeef0
FDA-2015-F-0537-0022 FDA FDA-2015-F-0537 BASF Corp Appendix C Chromatograms (Redacted) re: Supplemental Comments from BASF Corporation (Keller and Heckman LLP) Supporting & Related Material Background Material 2015-12-31T05:00:00Z 2015 12     2015-12-31T15:25:13Z   0 0 0900006481ddf21a
FDA-2015-F-0537-0021 FDA FDA-2015-F-0537 BASF Corp Appendix B Detailed Sample Analysis Data (Redacted) re: Supplemental Comments from BASF Corporation (Keller and Heckman LLP) Supporting & Related Material Background Material 2015-12-31T05:00:00Z 2015 12     2015-12-31T15:23:22Z   0 0 0900006481ddf219
FDA-2015-P-5108-0001 FDA FDA-2015-P-5108 Citizen Petition from Purdue Pharma L.P. (Kleinfeld, Kaplan and Becker, LLP) Other Citizen Petition 2015-12-31T05:00:00Z 2015 12 2015-12-31T05:00:00Z   2024-11-11T21:19:54Z   1 0 0900006481dd5e86
FDA-2014-E-1234-0004 FDA FDA-2014-E-1234 Letter from U.S. Patent and Trademark Office Other Letter(s) 2015-12-31T05:00:00Z 2015 12 2015-12-31T05:00:00Z   2015-12-31T16:38:33Z   0 0 0900006481ddf68c
FDA-2015-P-5108-0007 FDA FDA-2015-P-5108 Exhibit 6 NDA Review, NDA 20-553 E.D. Bashaw, PharmD, with Excerpts from Appendix to Review re Citizen Petition from Purdue Pharma L.P. (Kleinfeld, Kaplan and Becker, LLP) Supporting & Related Material Background Material 2015-12-31T05:00:00Z 2015 12     2015-12-31T19:32:06Z   0 0 0900006481dd7783
FDA-2015-H-5100-0001 FDA FDA-2015-H-5100 CTP CMP Case re Top Hat, Inc. d/b/a Top Hat Liquor Other Correspondence 2015-12-30T05:00:00Z 2015 12 2015-12-30T05:00:00Z   2016-04-26T15:43:31Z   0 0 0900006481ddc7cd
FDA-2015-V-0275-0004 FDA FDA-2015-V-0275 Acknowledgement Letter from FDA DDM to Intel Corporation Other Acknowledgement Letter/Receipt 2015-12-30T05:00:00Z 2015 12 2015-12-30T05:00:00Z   2015-12-30T18:41:03Z   0 0 0900006481ddc836
FDA-2015-H-5104-0001 FDA FDA-2015-H-5104 CTP CMP Case re Shanil Enterprises Inc. d/b/a Presto Gas / Shanil Food Mart Other Correspondence 2015-12-30T05:00:00Z 2015 12 2015-12-30T05:00:00Z   2016-04-20T10:48:57Z   0 0 0900006481ddcb52
FDA-2015-H-5096-0001 FDA FDA-2015-H-5096 CTP CMP Case re ANDREWJAMES, LLC d/b/a The Dog House Pub Other Correspondence 2015-12-30T05:00:00Z 2015 12 2015-12-30T05:00:00Z   2016-05-02T13:38:28Z   0 0 0900006481ddc4fc
FDA-2015-H-5098-0001 FDA FDA-2015-H-5098 CTP CMP Case re Shlok and Het LLC d/b/a New Krauszer’s Food Stores Other Correspondence 2015-12-30T05:00:00Z 2015 12 2015-12-30T05:00:00Z   2024-11-11T21:20:01Z   1 0 0900006481ddc7c9
FDA-2015-H-5085-0001 FDA FDA-2015-H-5085 CTP CMP Case re Walgreen Co. d/b/a Walgreens 5197 Other Correspondence 2015-12-30T05:00:00Z 2015 12 2015-12-30T05:00:00Z   2016-05-02T10:28:26Z   0 0 0900006481dd9e7b
FDA-2015-H-5090-0001 FDA FDA-2015-H-5090 CTP CMP Case re Baba Jawala Singh II Inc. d/b/a 7-Eleven Store 2606A Other Correspondence 2015-12-30T05:00:00Z 2015 12 2015-12-30T05:00:00Z   2024-11-11T21:16:53Z   1 0 0900006481ddaf2e
FDA-2015-H-5093-0001 FDA FDA-2015-H-5093 CTP CMP Case re Becker’s Newsmarket, Inc. d/b/a Becker’s Newsstand Other Correspondence 2015-12-30T05:00:00Z 2015 12 2015-12-30T05:00:00Z   2016-07-13T16:14:56Z   0 0 0900006481ddb4df
FDA-2015-H-5083-0001 FDA FDA-2015-H-5083 CTP CMP Case re Southworth Grocery, LLC d/b/a Southworth Grocery Other Correspondence 2015-12-30T05:00:00Z 2015 12 2015-12-30T05:00:00Z   2016-05-18T13:09:51Z   0 0 0900006481dd9e77
FDA-2015-H-5099-0001 FDA FDA-2015-H-5099 CTP CMP Case re Mayport Farmers Co-Op d/b/a Tesoro Other Correspondence 2015-12-30T05:00:00Z 2015 12 2015-12-30T05:00:00Z   2016-05-17T10:14:23Z   0 0 0900006481ddc7cb
FDA-2001-P-0123-0188 FDA Switch Status of Emergency Contraceptives from Rx to OTC FDA-2001-P-0123 Citizen Petition Denial Response from FDA CDER to Pharmicists Planning Service, Inc. Other Denial of Petition 2015-12-30T05:00:00Z 2015 12 2015-12-30T05:00:00Z   2015-12-30T16:57:30Z   0 0 0900006481ddc4ab
FDA-2015-H-5092-0001 FDA FDA-2015-H-5092 CTP CMP Case re Oak Smoke Shop Limited Liability Company d/b/a Oak Smoke Shop Other Correspondence 2015-12-30T05:00:00Z 2015 12 2015-12-30T05:00:00Z   2016-06-03T12:38:56Z   0 0 0900006481ddaf35
FDA-2015-H-5101-0001 FDA FDA-2015-H-5101 CTP CMP Case re Lee’s Supermarkets, Inc. d/b/a Miller’s Fresh Foods Other Correspondence 2015-12-30T05:00:00Z 2015 12 2015-12-30T05:00:00Z   2016-05-02T10:30:46Z   0 0 0900006481ddc7cf
FDA-2015-H-5103-0001 FDA FDA-2015-H-5103 CTP CMP Case re Beverage Island, Inc. d/b/a Beverage Island Other Correspondence 2015-12-30T05:00:00Z 2015 12 2015-12-30T05:00:00Z   2016-05-06T14:02:40Z   0 0 0900006481ddcb50
FDA-2015-V-0275-0003 FDA FDA-2015-V-0275 Variance Application from Intel Corporation Other Application for Variance (VAR) 2015-12-30T05:00:00Z 2015 12 2015-12-30T05:00:00Z   2015-12-30T18:39:51Z   0 0 0900006481ddca7e
FDA-2015-H-5087-0001 FDA FDA-2015-H-5087 CTP CMP Case re Beach Tobacco and Beer, LLC d/b/a Beach Tobacco and Beer Other Correspondence 2015-12-30T05:00:00Z 2015 12 2015-12-30T05:00:00Z   2016-04-27T12:13:18Z   0 0 0900006481ddb29a
FDA-2015-H-5091-0001 FDA FDA-2015-H-5091 CTP CMP Case re Mastafa Market, Inc. d/b/a Mastafa Market Other Correspondence 2015-12-30T05:00:00Z 2015 12 2015-12-30T05:00:00Z   2016-05-02T13:27:17Z   0 0 0900006481ddaf30
FDA-2015-H-5088-0001 FDA FDA-2015-H-5088 CTP CMP Case re AG-Land FS, Inc. d/b/a Fast Stop Other Correspondence 2015-12-30T05:00:00Z 2015 12 2015-12-30T05:00:00Z   2024-11-11T21:18:11Z   1 0 0900006481ddb29c
FDA-2015-H-5089-0001 FDA FDA-2015-H-5089 CTP CMP Case re American Liquor and Foodmart, LLC d/b/a Fast Stop Princeville Other Correspondence 2015-12-30T05:00:00Z 2015 12 2015-12-30T05:00:00Z   2024-11-11T21:19:37Z   1 0 0900006481ddb29e
FDA-2015-H-5094-0001 FDA FDA-2015-H-5094 CTP CMP Case re Charanjit Tucker d/b/a Delta Gas of South River Other Correspondence 2015-12-30T05:00:00Z 2015 12 2015-12-30T05:00:00Z   2016-04-20T10:45:50Z   0 0 0900006481ddb4e1
FDA-2006-P-0018-0044 FDA Switch Plan B and equivalent EC drugs from precription -only to OTC status without age restrictions, exempt from prescription-dispensing requirement any new drug eligible for filing an ANDA because of its equivalence to Plan B FDA-2006-P-0018 Citizen Petition Partial Approval and Denial Response from FDA CDER to State of Wisconsin (Department of Justice) Other Partial Petition Approval and Denial 2015-12-30T05:00:00Z 2015 12 2015-12-30T05:00:00Z   2015-12-30T19:38:40Z   0 0 0900006481ddc00b
FDA-2015-H-5095-0001 FDA FDA-2015-H-5095 CTP CMP Case re Sama Incorporation d/b/a Service Food Mart Other Correspondence 2015-12-30T05:00:00Z 2015 12 2015-12-30T05:00:00Z   2016-06-16T14:30:12Z   0 0 0900006481ddc507
FDA-2015-H-5082-0001 FDA FDA-2015-H-5082 CTP CMP Case re Family Dollar Stores of Louisiana, Inc. d/b/a Family Dollar Other Correspondence 2015-12-30T05:00:00Z 2015 12 2015-12-30T05:00:00Z   2024-11-11T21:18:25Z   1 0 0900006481dd9e75
FDA-2015-H-5084-0001 FDA FDA-2015-H-5084 CTP CMP Case re M and M of Bradenton, Inc. d/b/a Oasis Liquor and Lounge Other Correspondence 2015-12-30T05:00:00Z 2015 12 2015-12-30T05:00:00Z   2016-05-04T17:17:09Z   0 0 0900006481dd9e79
FDA-2010-D-0434-0028 FDA FDA-2010-D-0434 Acidified Foods; Draft Guidance for Industry; Withdrawal of Draft Guidance Notice Withdrawal 2015-12-30T05:00:00Z 2015 12 2015-12-30T05:00:00Z   2015-12-30T14:04:06Z 2015-32781 0 0 0900006481ddb9fb
FDA-2015-H-5086-0001 FDA FDA-2015-H-5086 CTP CMP Case re Dublin Corporation d/b/a Mickey Quinn’s Pub and Grill Other Correspondence 2015-12-30T05:00:00Z 2015 12 2015-12-30T05:00:00Z   2016-05-16T15:04:26Z   0 0 0900006481ddb298
FDA-2015-H-5097-0001 FDA FDA-2015-H-5097 CTP CMP Case re RPCS, Inc. d/b/a Price Cutter Other Correspondence 2015-12-30T05:00:00Z 2015 12 2015-12-30T05:00:00Z   2016-05-02T15:04:40Z   0 0 0900006481ddc900
FDA-2015-H-5057-0001 FDA FDA-2015-H-5057 CTP CMP Case re S and R Truck Plaza, LLC d/b/a Cenex Other Correspondence 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z   2024-11-11T21:18:22Z   1 0 0900006481dd7288
FDA-2015-H-5058-0001 FDA FDA-2015-H-5058 CTP CMP Case re American Gas and Oil, Inc. d/b/a Alpine BP 36 Other Correspondence 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z   2024-11-11T21:19:51Z   1 0 0900006481dd728a
FDA-2015-H-5072-0001 FDA FDA-2015-H-5072 CTP CMP Case re Thorntons Inc. d/b/a Thorntons Other Correspondence 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z   2024-11-11T21:19:03Z   1 0 0900006481dd8bf7
FDA-2015-H-5075-0001 FDA FDA-2015-H-5075 CTP CMP Case re Prayosa Krupa Inc. d/b/a Circle A Food Mart Other Correspondence 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z   2024-11-11T21:18:14Z   1 0 0900006481dd8dd3
FDA-2015-H-5077-0001 FDA FDA-2015-H-5077 CTP CMP Case re Prit LLC d/b/a Right Fuel and Food Other Correspondence 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z   2024-11-11T21:18:05Z   1 0 0900006481dd91a9
FDA-2015-H-5061-0001 FDA FDA-2015-H-5061 CTP CMP Case re Rania Mart LLC d/b/a Big T’s / Food Mart Other Correspondence 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z   2024-11-11T21:18:22Z   1 0 0900006481dd761c
FDA-2015-H-5063-0001 FDA FDA-2015-H-5063 CTP CMP Case re Dollar Value Stores, LLC d/b/a Dollar Value Other Correspondence 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z   2024-11-11T21:17:36Z   1 0 0900006481dd7620
FDA-2015-V-5067-0001 FDA FDA-2015-V-5067 Variance Application from DJ Troy Stumpf Other Application for Variance (VAR) 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z   2015-12-29T16:19:13Z   0 0 0900006481dd85d6
FDA-2015-H-5071-0001 FDA FDA-2015-H-5071 CTP CMP Case re Richardson and Sons, LLC d/b/a P and R Express / Marathon Other Correspondence 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z   2016-04-02T20:38:34Z   0 0 0900006481dd8bf3
FDA-2014-N-1210-0003 FDA FDA-2014-N-1210 Reference 1 - The Practice of Electroconvulsive Therapy - Recommendations for Treatment, Training and Privileging Supporting & Related Material Reference (external attachments) 2015-12-29T05:00:00Z 2015 12     2015-12-29T17:24:31Z   0 0 0900006481dd8bf6
FDA-2014-N-1210-0009 FDA FDA-2014-N-1210 Reference 7 - Antidepressant Drug Effects and Depression Severity: A Patient-Level Meta-Analysis Supporting & Related Material Reference (external attachments) 2015-12-29T05:00:00Z 2015 12     2015-12-29T17:23:16Z   0 0 0900006481dd8c8e
FDA-2015-N-2163-0008 FDA FDA-2015-N-2163 Reference 4 Prevalence of Hearing Loss in Older Adults in Beaver Dam, Wisconsin The Epidemiology of Hearing Loss Study Supporting & Related Material Reference (external attachments) 2015-12-29T05:00:00Z 2015 12     2015-12-29T20:54:05Z   0 0 0900006481dd9b29
FDA-2015-N-2163-0014 FDA FDA-2015-N-2163 Reference 12 The Associative Memory Deficit of Older Adults - Further Support Using Face-Name Associations Supporting & Related Material Reference (external attachments) 2015-12-29T05:00:00Z 2015 12     2015-12-29T21:04:35Z   0 0 0900006481dd9b95
FDA-2014-N-1210-0011 FDA FDA-2014-N-1210 Reference 9 - An Examination of Mortality and Other Adverse Events Related to Electroconvulsive Therapy Using a National Adverse Event Report System Supporting & Related Material Reference (external attachments) 2015-12-29T05:00:00Z 2015 12     2015-12-29T17:22:54Z   0 0 0900006481dd8e03
FDA-2015-N-2163-0013 FDA FDA-2015-N-2163 Reference 11 Task Coordination and Aging - Explorations of Executive Control Processes in the Task Switching Paradigm Supporting & Related Material Reference (external attachments) 2015-12-29T05:00:00Z 2015 12     2015-12-29T21:03:24Z   0 0 0900006481dd9b94
FDA-2000-D-0075-0213 FDA Voluntary Labeling for Bioengineered Foods FDA-2000-D-0075 Request for Extension from Josh Wilson Other Request for Extension 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z   2015-12-29T21:48:40Z   0 0 0900006481dcfb1d
FDA-2014-D-1318-0002 FDA FDA-2014-D-1318 Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses Draft Guidance for Industry, Clinicians and Food and Drug Administration Staff Other Guidance 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z   2024-11-11T21:19:55Z   1 0 0900006481dd91f1
FDA-2015-N-3469-0004 FDA FDA-2015-N-3469 Nomination from Imprimis Pharmaceuticals Other Nomination 2015-12-29T05:00:00Z 2015 12 2015-10-27T04:00:00Z   2017-07-14T20:11:34Z   0 0 0900006481dd6091
FDA-2015-V-5074-0002 FDA FDA-2015-V-5074 Acknowledgement Letter from FDA DDM to Lee Media Other Acknowledgement Letter/Receipt 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z   2015-12-30T14:48:29Z   0 0 0900006481dd8dd0
FDA-2015-N-2163-0006 FDA FDA-2015-N-2163 Reference 2 Age, Affective Experience, and Television Use Supporting & Related Material Reference (external attachments) 2015-12-29T05:00:00Z 2015 12     2015-12-29T20:45:12Z   0 0 0900006481dd986d
FDA-2015-N-2163-0011 FDA FDA-2015-N-2163 Reference 8 Speech Understanding in the Elderly Supporting & Related Material Reference (external attachments) 2015-12-29T05:00:00Z 2015 12     2015-12-29T21:00:29Z   0 0 0900006481dd9b8e
FDA-2015-H-5065-0001 FDA FDA-2015-H-5065 CTP CMP Case re Family Dollar Stores of New Jersey, Inc. d/b/a Family Dollar 05435 Other Correspondence 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z   2024-11-11T21:19:57Z   1 0 0900006481dd7456
FDA-2015-H-5064-0001 FDA FDA-2015-H-5064 CTP CMP Case re WL Green Grocers, Inc. d/b/a M and M Bagels and Deli Other Correspondence 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z   2024-11-11T21:17:42Z   1 0 0900006481dd7454
FDA-2015-H-5076-0001 FDA FDA-2015-H-5076 CTP CMP Case re F and T Mini Market LLC d/b/a F and T Meat Market Other Correspondence 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z   2024-11-11T21:17:43Z   1 0 0900006481dd8dd6
FDA-2014-N-1210-0006 FDA FDA-2014-N-1210 Reference 4 - Mental Health - A Report of the Surgeon General Supporting & Related Material Reference (external attachments) 2015-12-29T05:00:00Z 2015 12     2015-12-29T17:23:50Z   0 0 0900006481dd8c8b
FDA-2007-D-0369-0370 FDA FDA-2007-D-0369 Bioequivalence Recommendations for Paliperidone Palmitate; Draft Guidance for Industry; Availability Notice Notice of Availability 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z 2016-03-01T04:59:59Z 2016-02-29T22:00:18Z 2015-32723 0 0 0900006481dd74ac
FDA-2015-N-2163-0007 FDA FDA-2015-N-2163 Reference 3 Prevalence of Hearing Loss and Differences by Demographic Characteristics Among US Adults Supporting & Related Material Reference (external attachments) 2015-12-29T05:00:00Z 2015 12     2015-12-29T20:52:02Z   0 0 0900006481dd9b28
FDA-2015-N-4170-0001 FDA FDA-2015-N-4170 Establishment of a Public Docket; Clinical Trial Designs in Emerging Infectious Diseases Notice General Notice 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z 2016-01-29T04:59:59Z 2016-01-29T22:01:07Z 2015-32724 0 0 0900006481dd7a8b
FDA-2013-N-0242-0005 FDA FDA-2013-N-0242 Agency Information Collection Activities: Proposed Collection; Comment Request; Current Good Manufacturing Practice for Positron Emission Tomography Drugs Notice 60 Day Proposed Information Collection 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z 2016-03-01T04:59:59Z 2016-02-29T22:00:25Z 2015-32685 0 0 0900006481dd7930
FDA-2015-V-5079-0001 FDA FDA-2015-V-5079 Variance Application from Alamo Drafthouse Cinema Other Application for Variance (VAR) 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z   2015-12-29T18:02:13Z   0 0 0900006481dd9254
FDA-2014-N-1210-0004 FDA FDA-2014-N-1210 Reference 2 - Guidance on the Use of Electroconvulsive Therapy Supporting & Related Material Reference (external attachments) 2015-12-29T05:00:00Z 2015 12     2015-12-29T17:24:16Z   0 0 0900006481dd8bfa
FDA-2014-N-1210-0008 FDA FDA-2014-N-1210 Reference 6 - Clinical and Cost-Effectiveness of Electroconvulsive Therapy for Depressive Illness, Schizophrenia, Catatonia and Mania-Systematic Reviews and Economic Modelling Studies Supporting & Related Material Reference (external attachments) 2015-12-29T05:00:00Z 2015 12     2015-12-29T17:23:27Z   0 0 0900006481dd8c8d
FDA-2015-V-5074-0001 FDA FDA-2015-V-5074 Variance Application from Lee Media Other Application for Variance (VAR) 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z   2015-12-29T17:03:20Z   0 0 0900006481dd8893
FDA-2015-V-5067-0002 FDA FDA-2015-V-5067 Acknowledgement letter from FDA DDM to DJ Troy Stumpf Other Acknowledgement Letter/Receipt 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z   2015-12-30T14:31:59Z   0 0 0900006481dd8c45
FDA-2014-N-1210-0007 FDA FDA-2014-N-1210 Reference 5 - Objective Cognitive Performance Associated with Electroconvulsive Therapy for Depression- A Systematic Review and Meta-Analysis Supporting & Related Material Reference (external attachments) 2015-12-29T05:00:00Z 2015 12     2015-12-29T17:23:38Z   0 0 0900006481dd8c8c
FDA-2014-N-1210-0010 FDA FDA-2014-N-1210 Reference 8 - Initial Severity and Antidepressant Benefits- A Meta-Analysis of Data Submitted to the Food and Drug Administration Supporting & Related Material Reference (external attachments) 2015-12-29T05:00:00Z 2015 12     2015-12-29T17:23:04Z   0 0 0900006481dd8e02
FDA-2012-N-1021-0016 FDA FDA-2012-N-1021 Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2016 Proposed Guidance Development Notice Announcement 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z 2016-03-01T04:59:59Z 2016-04-29T16:00:21Z 2015-32726 0 0 0900006481dd79c0
FDA-2015-N-2163-0005 FDA FDA-2015-N-2163 Reference 1 Age and Sex Patterns of Drug Prescribing in a Defined American Population Supporting & Related Material Reference (external attachments) 2015-12-29T05:00:00Z 2015 12     2015-12-29T20:43:51Z   0 0 0900006481dd986c
FDA-2015-N-2163-0010 FDA FDA-2015-N-2163 Reference 7 Incidence of Hearing Decline in the Elderly Supporting & Related Material Reference (external attachments) 2015-12-29T05:00:00Z 2015 12     2015-12-29T20:58:30Z   0 0 0900006481dd9b5a
FDA-2015-H-5056-0001 FDA FDA-2015-H-5056 CTP CMP Case re Riz Petroleum Inc. d/b/a Stars Food and Deli Other Correspondence 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z   2024-11-11T21:17:50Z   1 0 0900006481dd7286
FDA-2015-H-5059-0001 FDA FDA-2015-H-5059 CTP CMP Case re Arthur Kharatyan d/b/a La Brea Newsstand / La Brea Cigarettes Other Correspondence 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z   2024-11-11T21:19:00Z   1 0 0900006481dd7618
FDA-2015-H-5060-0001 FDA FDA-2015-H-5060 CTP CMP Case re Gokie C-Stores, Inc. d/b/a Fast Mart Other Correspondence 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z   2024-11-11T21:16:24Z   1 0 0900006481dd761a
FDA-2015-H-5068-0001 FDA FDA-2015-H-5068 CTP CMP Case re Card Corporation d/b/a Kaders Party Shoppe Other Correspondence 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z   2024-11-11T21:19:44Z   1 0 0900006481dd8684
FDA-2015-H-5070-0001 FDA FDA-2015-H-5070 CTP CMP Case re Delbert Robinson d/b/a Low Bob’s Discount Tobacco Other Correspondence 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z   2024-11-11T21:18:11Z   1 0 0900006481dd8b4d
FDA-2015-H-5078-0001 FDA FDA-2015-H-5078 CTP CMP Case re Mami’s Food Market, LLC d/b/a Mami’s Food Market Other Correspondence 2015-12-29T05:00:00Z 2015 12 2015-12-29T05:00:00Z   2024-11-11T21:18:06Z   1 0 0900006481dd91af

Next page

Advanced export

JSON shape: default, array, newline-delimited, object

CSV options: 

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);