Drug Regulatory Affairs

Abstract

The Pharmaceutical System Project Management Office (PSPMO), an element of the U.S. Army Medical Materiel Development Activity (USAMMDA) holds the responsibility for planning, organizing, directing and controlling all aspects of drug development. Every stage of drug development must be in compliance with current FDA requirements. The principal objective of this contract is to prepare and assemble drug-specific, FDA-related documentation as well as a data management system to track the status of regulatory documentation. This initial Annual Report describes the work performed by the contractor for the 12 months period of June 2, 1986 to June 30, 1987.

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Document Details

Document Type
Technical Report
Publication Date
Jul 15, 1987
Accession Number
ADA200081

Entities

People

  • Arthur M. Horowitz

Tags

DTIC Thesaurus Topics

  • Biomedical Research
  • Blood
  • Contractors
  • Contracts
  • Cost Estimates
  • Databases
  • Diseases And Disorders
  • Engineering
  • Health Services
  • Lassa Fever
  • Medical Personnel
  • Phlebotomus Fever
  • Project Management
  • Vascular Diseases
  • Viral Hemorrhagic Fevers
  • Virus Diseases
  • Viruses

Fields of Study

  • Medicine

Readers

  • Clinical Trial Research.
  • Defense Financial Management and Audit.