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58 rows where docket_id = "FDA-2019-N-5711" sorted by posted_date descending
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document_type 5
- Supporting & Related Material 54
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- Proposed Rule 1
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agency_id 1
- FDA 58
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 |
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title TEXT,
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