MOA ON INVESTIGATIONAL USE OF DRUGS ANTIBIOTICS

File: 120396_sep96_decls20_0001.txt
Page: 0001
Total Pages: 5

Subject: MOA ON INVESTIGATIONAL USE OF DRUGS ANTIBIOTICS                 

Unit: OTSG        

Parent Organization: HSC         

Box ID: BX003203

Folder Title: MOU BETWEEN THE FOOD AND DRUG ADMINISTRATION AND DOD                                            

Document Number:          1

Folder SEQ  #:        133












                                 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 DEPARTMENT OF DEFENSE


                                         I. PURPOSE

                     This agreement between the Department of Defense (ooo)
                and the Food and Drug Administration (FDA) establishes the
                procedures to be followed regarding the investigational use
                of drugs, including antibiotics and biologics, and medical
                devices by DOD. This Memorandum of Understanding (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 505(i) and
                507(d) of the Act (21 U.S.C. 355(i), 357(d)) provide
                authority for the Secretary 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 device approval procedures devices which will be
                used for investigational purposes. Section 351 of the Public
                Health Service Act establishes procedures for the approval
a biological product can be introduced into
                interstate commerce.

                Regulations governing investigational new drugs,
                investigational antibiotics, and investigational biologics
                are published at 21 CFR 312; for investigational medical

Document 5 f:/Week-36/BX003203/MOU BETWEEN THE FOOD AND DRUG ADMINISTRATION AND DOD/moa on investigational use of drugs antibiotics:11089615090121
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003203
Unit = OTSG
Parent Organization = HSC
Folder Title = MOU BETWEEN THE FOOD AND DRUG ADMINISTRATION AND DOD
Folder Seq # = 133
Subject = MOA ON INVESTIGATIONAL USE OF DRUGS ANTIBIOTICS
Document Seq # = 1
Document Date =
Scan Date =
Queued for Declassification = 01-JAN-1980
Short Term Referral = 01-JAN-1980
Long Term Referral = 01-JAN-1980
Permanent Referral = 01-JAN-1980
Non-Health Related Document = 01-JAN-1980
Declassified = 08-NOV-1996