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withdrawn,object_id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(""Emerging Signals''); Draft Guidance for Industry and Food and Drug 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,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,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,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