Drug Regulatory Affairs

Abstract

The timely and efficient execution of the U.S. Army Medical Materiel Pharmaceutical Development Program requires a thorough knowledge of regulations issued by the U.S. Food and Drug Administration. In order to accomplish the execution of this drug development program, the Pharmaceutical System Project Management Office, an element of the U.S. Army Medical Materiel Development Activity (USAMMDA), awarded a multi-year contract to engineering and economics Research (EER) and its subcontractor, Oxford Research International Corporation (ORIC). The EER/ORIC team has provided the necessary managerial and technical expertise to complete the preparation and assembly of IND/NDAs. A total of 5 tasks were submitted to the contractor during the second contract year. All task orders were completed or are in progress within the projected delivery schedule and cost estimate. Keywords: Drugs; Synthesis; Drug development.

Open PDF

Document Details

Document Type
Technical Report
Publication Date
Jul 15, 1988
Accession Number
ADA206334

Entities

People

  • Arthur M. Horowitz

Tags

DTIC Thesaurus Topics

  • Acetylcholinesterases
  • Atropine
  • Contractors
  • Contracts
  • Control Systems
  • Correlation Analysis
  • Cost Estimates
  • Database Management Systems
  • Databases
  • Engineering
  • Information Science
  • Inhibition
  • Literature Surveys
  • Manufacturing
  • Personnel Management
  • Project Management
  • Virus Diseases

Readers

  • Clinical Trial Research.
  • Technical Research and Report Writing.