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File: aacxf_03.txt
MEMORANDUM OF UNDERSTANDING
Between the
FOOD AND DRUG ADMINISTRATION
and the
DEPARTMENT OF DEFENSE
CONCERNING INVESTIGATIONAL USE OF
DRUGS, ANTIBIOTICS, BIOLOGICS, AND
MEDICAL DEVICES BY THE DEPAATMENT OF DEFENSE
.
I. PURPOSE
This agreement between the Department of Defense (DOD)
and the Food and Drug Admin1stration (FOA) establishes the
procedures to be followed regarding the investigational use
of drugs, including antibiotics and biologics, and medical
devices by DoD. This Memorandum of Understending (MOU), when
signed by the representatives of the agencies, replaces the.
previous MOU on this subject signed in 1974
II BACKGROUND
Sections 505(a) and 507 of the Federal Food, Drug, and
Cosmetic Act ("the Act") establish procedures for the
approval required before a new drug or antibiotic can be
introduced into interstate commerce Sections 505S(i) and
507(d) of the Act (21 U S C 355(i), 357(d)) provide
authority for the Secretery to exempt from the drug approval
procedures new drugs and antibiotics which will be used for
investigational purposes. Section 520(g) of the Act (21
U S C 360(g)) provides authority for the Secretary to exempt
from the devic. approval procedures devices which will be
used for investigational purposes. Section 351 of the Public
Health Service Act establishes procedures for the approval
required before a biological product can be introduced into
interstate commerce.
Regulatlons governing investigational new drugs,
investigational antibiotics, and investigational biologics
are published at 21 CFR 312; for investigational medical
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