[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR314.2]

[Page 88]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 314.2  Purpose.

    The purpose of this part is to establish an efficient and thorough 
drug review process in order to: (a) Facilitate the approval of drugs 
shown to be safe and effective; and (b) ensure the disapproval of drugs 
not shown to be safe and effective. These regulations are also intended 
to establish an effective system for FDA's surveillance of marketed 
drugs. These regulations shall be construed in light of these 
objectives.