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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

The structure of the downloadable database file has changed.

Below you will find a link to download a compressed zip file of the postmarketing requirements (PMRs) and postmarketing commitments (PMCs) database.  This compressed zip file is updated each quarter, on or around the end of January, April, July, and October. This file includes PMRs and 506B PMCs which are those studies and trials for clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology. It also includes all open PMRs and 506B PMCs and only those closed (released or fulfilled) within the last year.

The compressed zip file contains a table of contents document, which includes a description of each document in the zip file. The data in the Excel or text file can be imported into a database, spreadsheet, or word processing program. Generally, a database program is the best program to use for structured data.

PMR/PMC Download

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