[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: 21CFR314.3]

[Page 88-89]
 
                        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. 314.3  Definitions.

    (a) The definitions and interpretations contained in section 201 of 
the act apply to those terms when used in this part.
    (b) The following definitions of terms apply to this part:
    Abbreviated application means the application described under 
Sec. 314.94, including all amendments and supplements to the 
application. ``Abbreviated application'' applies to both an abbreviated 
new drug application and an abbreviated antibiotic application.
    Act means the Federal Food, Drug, and Cosmetic Act (sections 201-901 
(21 U.S.C. 301-392)).
    Applicant means any person who submits an application or abbreviated 
application or an amendment or supplement to them under this part to 
obtain FDA approval of a new drug or an antibiotic drug and any person 
who owns an approved application or abbreviated application.
    Application means the application described under Sec. 314.50, 
including all amendements and supplements to the application.
    505(b)(2) Application means an application submitted under section 
505(b)(1) of the act for a drug for which the investigations described 
in section 505(b)(1)(A) of the act and relied upon by the applicant for 
approval of the application were not conducted by or for the applicant 
and for which the applicant has not obtained a right of reference or use 
from the person by or for whom the investigations were conducted.
    Approvable letter means a written communication to an applicant from 
FDA stating that the agency will approve the application or abbreviated

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application if specific additional information or material is submitted 
or specific conditions are met. An approvable letter does not constitute 
approval of any part of an application or abbreviated application and 
does not permit marketing of the drug that is the subject of the 
application or abbreviated application.
    Approval letter means a written communication to an applicant from 
FDA approving an application or an abbreviated application.
    Drug product means a finished dosage form, for example, tablet, 
capsule, or solution, that contains a drug substance, generally, but not 
necessarily, in association with one or more other ingredients.
    Drug substance means an active ingredient that is intended to 
furnish pharmacological activity or other direct effect in the 
diagnosis, cure, mitigation, treatment, or prevention of disease or to 
affect the structure or any function of the human body, but does not 
include intermediates use in the synthesis of such ingredient.
    FDA means the Food and Drug Administration.
    Listed drug means a new drug product that has an effective approval 
under section 505(c) of the act for safety and effectiveness or under 
section 505(j) of the act, which has not been withdrawn or suspended 
under section 505(e)(1) through (e)(5) or (j)(5) of the act, and which 
has not been withdrawn from sale for what FDA has determined are reasons 
of safety or effectiveness. Listed drug status is evidenced by the drug 
product's identification as a drug with an effective approval in the 
current edition of FDA's ``Approved Drug Products with Therapeutic 
Equivalence Evaluations'' (the list) or any current supplement thereto, 
as a drug with an effective approval. A drug product is deemed to be a 
listed drug on the date of effective approval of the application or 
abbreviated application for that drug product.
    Not approvable letter means a written communication to an applicant 
from FDA stating that the agency does not consider the application or 
abbreviated application approvable because one or more deficiencies in 
the application or abbreviated application preclude the agency from 
approving it.
    Reference listed drug means the listed drug identified by FDA as the 
drug product upon which an applicant relies in seeking approval of its 
abbreviated application.
    Right of reference or use means the authority to rely upon, and 
otherwise use, an investigation for the purpose of obtaining approval of 
an application, including the ability to make available the underlying 
raw data from the investigation for FDA audit, if necessary.
    The list means the list of drug products with effective approvals 
published in the current edition of FDA's publication ``Approved Drug 
Products with Therapeutic Equivalence Evaluations'' and any current 
supplement to the publication.

[50 FR 7493, Feb. 22, 1985, as amended at 57 FR 17981, Apr. 28, 1992]