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withdrawn,object_id FDA-2019-N-5711-1260,FDA,FDA-2019-N-5711,RIA_REF1 RE Final rule ref 06 Final Regulatory Impact Analysis,Supporting & Related Material,Background Material,2020-11-24T05:00:00Z,2020,11,,,2020-11-24T17:21:16Z,,0,0,09000064848762d8 FDA-2019-N-5711-1267,FDA,FDA-2019-N-5711,RIA_REF8 RE Final rule ref 06 Final Regulatory Impact Analysis,Supporting & Related Material,Background Material,2020-11-24T05:00:00Z,2020,11,,,2020-11-24T17:22:16Z,,0,0,09000064848765cd FDA-2019-N-5711-1257,FDA,FDA-2019-N-5711,"Final rule ref 04 Government of Canada, Consultation Regulations Amending the Food and Drug Regulations 1447-Good Manufacturing Practices",Supporting & Related Material,Background Material,2020-11-24T05:00:00Z,2020,11,,,2020-11-24T17:17:55Z,,0,0,090000648486ac43 FDA-2019-N-5711-1263,FDA,FDA-2019-N-5711,RIA_REF4 RE Final rule ref 06 Final Regulatory Impact Analysis,Supporting & Related Material,Background Material,2020-11-24T05:00:00Z,2020,11,,,2020-11-24T17:21:43Z,,0,0,09000064848765c9 FDA-2019-N-5711-1258,FDA,FDA-2019-N-5711,"Final rule ref 05 Government of Canada, Health Canada, GMP Drug Establishment Good Manufacturing Practices Pre-Application Package Importers, Distributors and Wholesalers",Supporting & Related Material,Background Material,2020-11-24T05:00:00Z,2020,11,,,2020-11-24T17:18:17Z,,0,0,090000648486ac44 FDA-2019-N-5711-1265,FDA,FDA-2019-N-5711,RIA_REF6 RE Final rule ref 06 Final Regulatory Impact Analysis,Supporting & Related Material,Background Material,2020-11-24T05:00:00Z,2020,11,,,2020-11-24T17:22:01Z,,0,0,09000064848765cb FDA-2019-N-5711-1259,FDA,FDA-2019-N-5711,Final rule ref 06 Final Regulatory Impact Analysis,Other,Additional Information,2020-11-24T05:00:00Z,2020,11,2020-11-24T05:00:00Z,,2020-11-24T17:18:51Z,,0,0,09000064848762d6 FDA-2019-N-5711-1256,FDA,FDA-2019-N-5711,Final rule ref 03 HHS Report on Prescription Drug Importation,Supporting & Related Material,Background Material,2020-11-24T05:00:00Z,2020,11,,,2020-11-24T17:17:30Z,,0,0,090000648486ac42 FDA-2019-N-5711-1262,FDA,FDA-2019-N-5711,RIA_REF3 RE Final rule ref 06 Final Regulatory Impact Analysis,Supporting & Related Material,Background Material,2020-11-24T05:00:00Z,2020,11,,,2020-11-24T17:21:35Z,,0,0,09000064848762da FDA-2019-N-5711-1268,FDA,FDA-2019-N-5711,RIA_REF9 RE Final rule ref 06 Final Regulatory Impact Analysis,Supporting & Related Material,Background Material,2020-11-24T05:00:00Z,2020,11,,,2020-11-24T17:22:25Z,,0,0,09000064848765ce FDA-2019-N-5711-1266,FDA,FDA-2019-N-5711,RIA_REF7 RE Final rule ref 06 Final Regulatory Impact Analysis,Supporting & Related Material,Background Material,2020-11-24T05:00:00Z,2020,11,,,2020-11-24T17:22:09Z,,0,0,09000064848765cc FDA-2019-N-5711-1255,FDA,FDA-2019-N-5711,Final rule ref 02 Internet Pharmacy Warning Letters _ FDA,Supporting & Related Material,Background Material,2020-11-24T05:00:00Z,2020,11,,,2020-11-24T17:17:09Z,,0,0,090000648486ac41 FDA-2019-N-5711-1264,FDA,FDA-2019-N-5711,RIA_REF5 RE Final rule ref 06 Final Regulatory Impact Analysis,Supporting & Related Material,Background Material,2020-11-24T05:00:00Z,2020,11,,,2020-11-24T17:21:51Z,,0,0,09000064848765ca FDA-2019-N-5711-1254,FDA,FDA-2019-N-5711,"Final rule ref 01 FDA launches global operation to crack down on websites selling illegal, potentially dangerous drugs; including opioids _ FDA",Supporting & Related Material,Background Material,2020-11-24T05:00:00Z,2020,11,,,2020-11-24T17:16:47Z,,0,0,09000064848693a0 FDA-2019-N-5711-1261,FDA,FDA-2019-N-5711,RIA_REF2 RE Final rule ref 06 Final Regulatory Impact Analysis,Supporting & Related Material,Background Material,2020-11-24T05:00:00Z,2020,11,,,2020-11-24T17:21:26Z,,0,0,09000064848762d9 FDA-2019-N-5711-1253,FDA,FDA-2019-N-5711,"Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals",Notice,Notice of Approval,2020-11-12T05:00:00Z,2020,11,2020-11-12T05:00:00Z,,2023-03-29T14:23:00Z,2020-25019,0,0,090000648495a209 FDA-2019-N-5711-1252,FDA,FDA-2019-N-5711,Importation of Prescription Drugs,Rule,Final Rule,2020-10-01T04:00:00Z,2020,10,2020-10-01T04:00:00Z,,2020-10-01T14:54:00Z,2020-21522,0,0,09000064848abb2b FDA-2019-N-5711-0012,FDA,FDA-2019-N-5711,Ref. 09. Iuga and McGuire 2014 Adherence and Health Care Costs Risk Management and Healthcare Policy re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:42:46Z,,0,0,090000648420d86e FDA-2019-N-5711-0028,FDA,FDA-2019-N-5711,Ref. 25. Ashley 2017 Letter to the Editor The Price of Crossing the Border for Medications NEJM re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:45:07Z,,0,0,090000648420d886 FDA-2019-N-5711-0037,FDA,FDA-2019-N-5711,Reference 4 Medicine Use and Spending in the US A Review of 2018 and Outlook to 2023 re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:46:18Z,,0,0,090000648420d89b FDA-2019-N-5711-0035,FDA,FDA-2019-N-5711,Reference 2 Higher US Branded Drug Prices And Spending Compared To Other Countries May Stem Partly From Quick Uptake Of New Drugs re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:46:02Z,,0,0,090000648420d899 FDA-2019-N-5711-0005,FDA,FDA-2019-N-5711,Ref. 02. Mark McClellan FDA Commissioner 2003 Letter to Senator Thad Cochran re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:41:49Z,,0,0,090000648420d83d FDA-2019-N-5711-0026,FDA,FDA-2019-N-5711,Ref. 23. FDA 2012 Warning Letter to Canadadrugs re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:44:51Z,,0,0,090000648420d883 FDA-2019-N-5711-0034,FDA,FDA-2019-N-5711,Reference 1 - Commercial Importation of Prescription Drugs in the United States Short-Run Implications Re: Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:45:55Z,,0,0,090000648420d898 FDA-2019-N-5711-0036,FDA,FDA-2019-N-5711,Reference 3 International Prices And Availability Of Pharmaceuticals In 2005 re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:46:09Z,,0,0,090000648420d89a FDA-2019-N-5711-0010,FDA,FDA-2019-N-5711,Ref. 07. HHS 2016 ASPE Issue Brief Observations on Trends in Prescription Drug Spending re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:42:30Z,,0,0,090000648420d86c FDA-2019-N-5711-0039,FDA,FDA-2019-N-5711,"Reference 6 Pharmaceutical trends Retail Prescriptions Dispensed in Canada, 2014-2018 re Importation of Prescription Drugs",Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:46:34Z,,0,0,090000648420d8a0 FDA-2019-N-5711-0015,FDA,FDA-2019-N-5711,Ref. 12. John Thomas 2016 Congressional Research Service Patents and Prescription Drug Importation re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:43:23Z,,0,0,090000648420d871 FDA-2019-N-5711-0017,FDA,FDA-2019-N-5711,Ref. 14. Gagnon and Wolfe 2015 Mirror Mirror on the Wall Medicare Part D re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:43:39Z,,0,0,090000648420d873 FDA-2019-N-5711-0018,FDA,FDA-2019-N-5711,Ref. 15. PMPRB Annual Report 2017 re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:43:47Z,,0,0,090000648420d87a FDA-2019-N-5711-0022,FDA,FDA-2019-N-5711,Ref. 19. FDA 2018 Global Operation re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:44:21Z,,0,0,090000648420d87f FDA-2019-N-5711-0040,FDA,FDA-2019-N-5711,"Reference 7 Preliminary Estimate - S. 469, the Affordable and Safe Prescription Drug Importation Act (as introduced) re Importation of Prescription Drugs",Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:46:42Z,,0,0,090000648420d8a1 FDA-2019-N-5711-0031,FDA,FDA-2019-N-5711,Ref. 28. Health Canada 2019 Joint Public Consultation on ICH Guidelines Update re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:45:31Z,,0,0,090000648420d889 FDA-2019-N-5711-0033,FDA,FDA-2019-N-5711,Ref. 30. ASTM E122-17 re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:45:47Z,,0,0,090000648420d88b FDA-2019-N-5711-0009,FDA,FDA-2019-N-5711,Ref. 06. GAO-18-40 re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:42:22Z,,0,0,090000648420d86b FDA-2019-N-5711-0023,FDA,FDA-2019-N-5711,Ref. 20. DOJ 2017 Millions of Medicines Seized in Largest INTERPOL Operation Against Illicit Online Pharmacies re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:44:28Z,,0,0,090000648420d880 FDA-2019-N-5711-0032,FDA,FDA-2019-N-5711,Ref. 29. Joanne Eglovitch 2019 GS1 Standard Would Speed the Sale of Returned Drugs After November Deadline Pink Sheet re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:45:39Z,,0,0,090000648420d88a FDA-2019-N-5711-0038,FDA,FDA-2019-N-5711,Reference 5 Patented Medicine Prices Review Board Annual Report 2017 re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:46:27Z,,0,0,090000648420d89f FDA-2019-N-5711-0042,FDA,FDA-2019-N-5711,Reference 9 Would Prescription Drug Importation Reduce U.S. Drug Spending re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:47:00Z,,0,0,090000648420d8a3 FDA-2019-N-5711-0004,FDA,FDA-2019-N-5711,Ref. 01. Donna Shalala Secretary of Health and Human Services 2000 Letter to President Clinton re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:41:27Z,,0,0,090000648420d83c FDA-2019-N-5711-0016,FDA,FDA-2019-N-5711,Ref. 13. Ben Hirschler 2015 How the US Pays 3 Times More for Drugs Scientific American re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:43:31Z,,0,0,090000648420d872 FDA-2019-N-5711-0041,FDA,FDA-2019-N-5711,Reference 8 Report on Prescription Drug Importation re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:46:50Z,,0,0,090000648420d8a2 FDA-2019-N-5711-0008,FDA,FDA-2019-N-5711,Ref. 05. HHS Task Force on Drug Importation 2004 Report on Prescription Drug Importation re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:42:14Z,,0,0,090000648420d86a FDA-2019-N-5711-0011,FDA,FDA-2019-N-5711,Ref. 08. KFF Health Tracking Poll February 2019 Prescription Drugs re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:42:38Z,,0,0,090000648420d86d FDA-2019-N-5711-0021,FDA,FDA-2019-N-5711,Ref. 18. KFF Health Tracking Poll November 2016 re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:44:09Z,,0,0,090000648420d87e FDA-2019-N-5711-0013,FDA,FDA-2019-N-5711,Ref. 10. Jonel Aleccia 2019 Lawmakers Advocates NPR re Importation of Prescription Drugs re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:42:53Z,,0,0,090000648420d86f FDA-2019-N-5711-0029,FDA,FDA-2019-N-5711,Ref. 26. Canada Consultation Regulations Amending the Food and Drug Regulations 1447 Good Manufacturing Practices re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:45:15Z,,0,0,090000648420d887 FDA-2019-N-5711-0006,FDA,FDA-2019-N-5711,Ref. 03. Randall Lutter Acting Associate Commissioner for Policy and Planning 2005 Letter to Theodore Kulongoski re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:41:58Z,,0,0,090000648420d83e FDA-2019-N-5711-0027,FDA,FDA-2019-N-5711,Ref. 24. FDA 2005 FDA Operation Reveals Many Drugs Promoted as Canadian Products Really Originate From Other Countries re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:44:59Z,,0,0,090000648420d885 FDA-2019-N-5711-0007,FDA,FDA-2019-N-5711,Ref. 04. Nomination of Robert Califf to Serve as FDA Commissioner 2015 re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:42:06Z,,0,0,090000648420d83f FDA-2019-N-5711-0024,FDA,FDA-2019-N-5711,Ref. 21. DOJ 2013 Paul Daniel Bottomley Pleads Guilty in US Federal Court re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:44:36Z,,0,0,090000648420d881 FDA-2019-N-5711-0014,FDA,FDA-2019-N-5711,Ref. 11. Liz Szabo 2017 As Drug Costs Soar People Delay or Skip Cancer Treatments National Public Radio re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:43:01Z,,0,0,090000648420d870 FDA-2019-N-5711-0019,FDA,FDA-2019-N-5711,Ref. 16. PMPRB Mandate and Jurisdiction re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:43:53Z,,0,0,090000648420d87c FDA-2019-N-5711-0020,FDA,FDA-2019-N-5711,Ref. 17. Rachel Bluth 2016 Faced with Unaffordable Drug Prices Tens of Millions Buy Medicine Outside US Kaiser Health News re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:44:01Z,,0,0,090000648420d87d FDA-2019-N-5711-0025,FDA,FDA-2019-N-5711,Ref. 22. DOJ 2018 Canadian Drug Firm re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:44:43Z,,0,0,090000648420d882 FDA-2019-N-5711-0030,FDA,FDA-2019-N-5711,Ref. 27. Health Canada GMP Drug Establishment re Importation of Prescription Drugs,Supporting & Related Material,Background Material,2020-01-06T05:00:00Z,2020,1,,,2020-01-06T20:45:23Z,,0,0,090000648420d888 FDA-2019-N-5711-0001,FDA,FDA-2019-N-5711,Importation of Prescription Drugs,Proposed Rule,Amendment,2019-12-23T05:00:00Z,2019,12,2019-12-23T05:00:00Z,2020-03-10T03:59:59Z,2022-01-18T02:00:13Z,2019-27474,0,0,090000648424842c FDA-2019-N-5711-0002,FDA,FDA-2019-N-5711,Importation of Prescription Drugs PRIA document,Supporting & Related Material,Background Material,2019-12-23T05:00:00Z,2019,12,,,2019-12-23T17:11:22Z,,0,0,090000648424a5a9