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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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29 rows where docket_id = "FDA-2011-N-0898" and posted_year = 2015 sorted by posted_date descending

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document_type 2

  • Supporting & Related Material 28
  • Rule 1

posted_year 1

  • 2015 · 29 ✖

agency_id 1

  • FDA 29
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2011-N-0898-0058 FDA None FDA-2011-N-0898 Reference 8 National Survey on the Effect of Oncology Drug Shortages on Cancer Care Supporting & Related Material Background Material 2015-07-08T04:00:00Z 2015 7     2015-07-08T15:17:20Z   0 0 0900006481b7171f
FDA-2011-N-0898-0062 FDA None FDA-2011-N-0898 Reference 12 Drug Shortages Delay Cancer Clinical Trials Supporting & Related Material Background Material 2015-07-08T04:00:00Z 2015 7     2015-07-08T15:18:52Z   0 0 0900006481b71723
FDA-2011-N-0898-0063 FDA None FDA-2011-N-0898 Reference 13 Executive Order 13588 - Reducing Prescription Drug Shortages Supporting & Related Material Background Material 2015-07-08T04:00:00Z 2015 7     2015-07-09T14:55:23Z   0 0 0900006481b71724
FDA-2011-N-0898-0061 FDA None FDA-2011-N-0898 Reference 11 Buyer Beware: Drug Shortages and the Gray Market Supporting & Related Material Background Material 2015-07-08T04:00:00Z 2015 7     2015-07-08T15:18:25Z   0 0 0900006481b71722
FDA-2011-N-0898-0055 FDA None FDA-2011-N-0898 Reference 5 Clinical Science Symposium, Bridging Evidence to Clinical Care: Cost and Availability of Treatment Supporting & Related Material Background Material 2015-07-08T04:00:00Z 2015 7     2015-07-08T15:16:35Z   0 0 0900006481b7171c
FDA-2011-N-0898-0060 FDA None FDA-2011-N-0898 Reference 10 Drug Shortages: National Survey Reveals High Level of Frustration, Low Level of Safety Supporting & Related Material Background Material 2015-07-08T04:00:00Z 2015 7     2015-07-08T15:18:16Z   0 0 0900006481b71721
FDA-2011-N-0898-0051 FDA None FDA-2011-N-0898 Reference 1 Executive Order 13588—Reducing Prescription Drug Shortages Supporting & Related Material Background Material 2015-07-08T04:00:00Z 2015 7     2015-07-09T14:31:46Z   0 0 0900006481b71594
FDA-2011-N-0898-0049 FDA None FDA-2011-N-0898 Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products Rule Final Rule 2015-07-08T04:00:00Z 2015 7 2015-07-08T04:00:00Z   2015-07-10T17:12:21Z 2015-16659 0 0 0900006481b71397
FDA-2011-N-0898-0071 FDA None FDA-2011-N-0898 Reference 21 - Are We Finally Winning the War on Cancer Supporting & Related Material Background Material 2015-07-08T04:00:00Z 2015 7     2015-07-08T15:22:29Z   0 0 0900006481b7172c
FDA-2011-N-0898-0074 FDA None FDA-2011-N-0898 Reference 24 - Occupational Employment Statistics Query Survey Supporting & Related Material Background Material 2015-07-08T04:00:00Z 2015 7     2015-07-08T15:23:20Z   0 0 0900006481b7172f
FDA-2011-N-0898-0067 FDA None FDA-2011-N-0898 Reference 17 Impact of Drug Shortages on U.S. Health Systems Supporting & Related Material Background Material 2015-07-08T04:00:00Z 2015 7     2015-07-08T15:20:20Z   0 0 0900006481b71728
FDA-2011-N-0898-0077 FDA None FDA-2011-N-0898 Reference 27 - American FactFinder - Results Supporting & Related Material Background Material 2015-07-08T04:00:00Z 2015 7     2015-07-08T15:24:01Z   0 0 0900006481b71732
FDA-2011-N-0898-0059 FDA None FDA-2011-N-0898 Reference 9 National Survey of the Impact of Drug Shortages in Acute Care Hospitals Supporting & Related Material Background Material 2015-07-08T04:00:00Z 2015 7     2015-07-08T15:17:30Z   0 0 0900006481b71720
FDA-2011-N-0898-0070 FDA None FDA-2011-N-0898 Reference 20 - A Review of Industry Aides Found at Least 15 Deaths in the Last 15 Months from a Lack of Available Medicine Supporting & Related Material Background Material 2015-07-08T04:00:00Z 2015 7     2015-07-09T15:00:46Z   0 0 0900006481b7172b
FDA-2011-N-0898-0073 FDA None FDA-2011-N-0898 Reference 23 - An Economic Evaluation of the War on Cancer Supporting & Related Material Background Material 2015-07-08T04:00:00Z 2015 7     2015-07-08T15:23:08Z   0 0 0900006481b7172e
FDA-2011-N-0898-0052 FDA None FDA-2011-N-0898 Reference 2 Manual of Policies and Procedures Supporting & Related Material Background Material 2015-07-08T04:00:00Z 2015 7     2015-07-09T14:34:47Z   0 0 0900006481b71595
FDA-2011-N-0898-0054 FDA None FDA-2011-N-0898 Reference 4 Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products; Final Rule Supporting & Related Material Background Material 2015-07-08T04:00:00Z 2015 7     2015-07-08T15:16:24Z   0 0 0900006481b7171b
FDA-2011-N-0898-0068 FDA None FDA-2011-N-0898 Reference 18 - Gray Market, Black Heart: Pharmaceutical Gray Market Finds a Disturbing Niche During the Drug Shortage Crisis Supporting & Related Material Background Material 2015-07-08T04:00:00Z 2015 7     2015-07-08T15:20:34Z   0 0 0900006481b71729
FDA-2011-N-0898-0076 FDA None FDA-2011-N-0898 Reference 26 - U. S. Small Business Administration Table of Small Business Size Standards Matched to North American Industry Classification System Codes Supporting & Related Material Background Material 2015-07-08T04:00:00Z 2015 7     2015-07-08T15:23:49Z   0 0 0900006481b71731
FDA-2011-N-0898-0053 FDA None FDA-2011-N-0898 Reference 3 SOPP 8506: Management of Shortages of CBER-Regulated Products Supporting & Related Material Background Material 2015-07-08T04:00:00Z 2015 7     2015-07-08T15:16:15Z   0 0 0900006481b7171a
FDA-2011-N-0898-0069 FDA None FDA-2011-N-0898 Reference 19 - Navigating Drug Shortages in American Healthcare: A Premier healthcare alliance analysis Supporting & Related Material Background Material 2015-07-08T04:00:00Z 2015 7     2015-07-08T15:20:44Z   0 0 0900006481b7172a
FDA-2011-N-0898-0072 FDA None FDA-2011-N-0898 Reference 22 - The Value of Health and Longevity Supporting & Related Material Background Material 2015-07-08T04:00:00Z 2015 7     2015-07-08T15:22:45Z   0 0 0900006481b7172d
FDA-2011-N-0898-0050 FDA None FDA-2011-N-0898 List of References re Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products Supporting & Related Material Background Material 2015-07-08T04:00:00Z 2015 7     2015-07-09T14:27:29Z   0 0 0900006481b71593
FDA-2011-N-0898-0057 FDA None FDA-2011-N-0898 Reference 7 A Shortage of Everything Except Errors: Harm Associated with Drug Shortages Supporting & Related Material Background Material 2015-07-08T04:00:00Z 2015 7     2015-07-08T15:17:10Z   0 0 0900006481b7171e
FDA-2011-N-0898-0056 FDA None FDA-2011-N-0898 Reference 6 2012 ASA Drug Shortage Survey Results Supporting & Related Material Background Material 2015-07-08T04:00:00Z 2015 7     2015-07-08T15:16:46Z   0 0 0900006481b7171d
FDA-2011-N-0898-0075 FDA None FDA-2011-N-0898 Reference 25 - The Effect of FDA Advisories on Branded Pharmaceutical Firms' Valuations and Promotion Efforts Supporting & Related Material Background Material 2015-07-08T04:00:00Z 2015 7     2015-07-09T15:04:40Z   0 0 0900006481b71730
FDA-2011-N-0898-0064 FDA None FDA-2011-N-0898 Reference 14 - Letter to Industry Supporting & Related Material Background Material 2015-07-08T04:00:00Z 2015 7     2015-07-08T15:19:19Z   0 0 0900006481b71725
FDA-2011-N-0898-0066 FDA None FDA-2011-N-0898 Reference 16 A Review of FDA’s Approach to Medical Product Shortages Supporting & Related Material Background Material 2015-07-08T04:00:00Z 2015 7     2015-07-08T15:19:52Z   0 0 0900006481b71727
FDA-2011-N-0898-0065 FDA None FDA-2011-N-0898 Reference 15 - Federal Register Volume 76 Issue 243 Supporting & Related Material Background Material 2015-07-08T04:00:00Z 2015 7     2015-07-08T15:19:36Z   0 0 0900006481b71726

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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;
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