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  4. Postmarketing Requirements and Commitments: Introduction
  5. Postmarketing Requirements and Commitments: Downloadable Database File
  1. Postmarketing Requirements and Commitments: Introduction

Postmarketing Requirements and Commitments: Downloadable Database File

Below you will find a compressed data file of the Postmarketing Requirements and Commitments database. All fields are double-quoted and separated by tabs.  Each table's primary key, data types, field lengths and nulls appear in the list below. This data file is updated once per quarter, at the end of  January, April, July, and October.

Once you have downloaded the compressed file (pmc.zip), you can unzip the file into two text tables. You can then import the tables into a database, spreadsheet, or word processing program. Generally, a database program is the best program to use for these types of files. We can offer little guidance on how to construct your database design, as each user has different requirements or uses.  

PMC Download

 The database consists of two tables:

  • PMC_CMT_STATUS
    • CMT_Status, nvarchar, 25
    • Status_Desc, nvarchar, 30, nulls
    • SortOrder, int, 4, nulls
  • PMC_COMMITMENTS
    • CMT_ID, int, 4
    • CMT_NUMBER, int, 4, nulls
    • CMT_DOC_TYPE nvarchar, 5, nulls
    • CMT_DOC_TYPE_NO, nvarchar, 5, nulls
    • CMT_DESC, ntext, 16, nulls
    • CMT_STATUS, nvarchar, 1, nulls
    • CMT_STATUS_DESC, nvarchar, 2500, nulls
    • STUDY_TYPE, nvarchar, 50, nulls
    • STUDY_START_DATE, smalldatetime, 4, nulls
    • PROTOCOL_SUMISSION DATE, smalldatetime, 4, nulls
    • FINAL_RPT_RECV_DATE, smalldatetime, 4, nulls
    • ANNUAL_RPT_DUE_DATE, smalldatetime, 4, nulls
    • ANNUAL_RPT_RECV_DATE, smalldatetime, 4, nulls
    • NDA_BLA_APPROVAL_DATE, smalldatetime, 4, nulls
    • ORIG_PROJ_COMPL_DATE, smalldatetime, 4, nulls
    • CURRENT_PROJ_COMPL_DATE, smalldatetime, 4, nulls
    • NDA_NUMBER, int, 4, nulls
    • APPLICANT, nvarchar, 250, nulls
    • PRODUCT, nvarchar, 250, nulls
    • CDER_OR_CBER, nvarchar, 2, nulls
    • SUBPART_FLAG, nvarchar, 1, nulls