home / openregs

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

58 rows where docket_id = "FDA-2019-N-5711" sorted by posted_date descending

✎ View and edit SQL

This data as json, CSV (advanced)

Suggested facets: subtype, posted_date, posted_month, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

document_type 5

  • Supporting & Related Material 54
  • Notice 1
  • Other 1
  • Proposed Rule 1
  • Rule 1

posted_year 2

  • 2020 56
  • 2019 2

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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

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);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;
Powered by Datasette · Queries took 26.708ms · Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API