Application of Food and Drug Administration (FDA) Rules to Department of Defense Force Health Protection Programs

Abstract

This Instruction: (1.1) Reissues Reference (a) as a DoD Instruction in accordance with the guidance in Reference (b) and the authority in Reference (c); (1.2) Updates policy and assigns responsibility for compliance with Reference (d); sections 1107 and 1107a of title 10, United States Code (U.S.C.) (Reference (e)); Executive Order 13139 (Reference (f)); and Parts 50, 56, 312, Subpart I of Part 314, Subpart G of Part 601 of title 21, Code of Federal Regulations (Reference (g)), for application of FDA rules to force health protection programs of the Department of Defense involving medical products required to be used under an Emergency Use Authorization (EUA) or an investigational new drug (IND) application; and (1.3) Incorporates responsibilities of the Secretary of the Army as the Lead Component for the use of medical products under EUAs or IND applications.

Open PDF

Document Details

Document Type
Technical Report
Publication Date
Feb 27, 2008
Accession Number
ADA594572

Entities

Organizations

  • United States Department of Defense

Tags

DTIC Thesaurus Topics

  • Biological Products
  • Biomedical Research
  • Combatant Commanders
  • Department Of Defense
  • Emergencies
  • Health
  • Health Care
  • Homeland Security
  • Institutional Review Board
  • Medical Countermeasures
  • Military Operations
  • Military Personnel
  • National Security
  • Public Health
  • Public Health Emergencies
  • Security
  • United States

Readers

  • Critical Infrastructure Protection in CBRN and WMD Threats.
  • Defense Financial Management and Audit.
  • Infectious Disease/Epidemiology