[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR314.105]

[Page 141-142]
 
                        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 D--FDA Action on Applications and Abbreviated Applications
 
Sec. 314.105  Approval of an application and an abbreviated application.

    (a) The Food and Drug Administration will approve an application and 
send the applicant an approval letter if none of the reasons in 
Sec. 314.125 for refusing to approve the application applies. An 
approval becomes effective on the date of the issuance of the approval 
letter, except with regard to an approval under section 505(b)(2) of the 
act with a delayed effective date. An approval with a delayed effective 
date is tentative and does not become final until the effective date. A 
new drug product or antibiotic approved under this paragraph may not be 
marketed until an approval is effective.
    (b) FDA will approve an application and issue the applicant an 
approval letter (rather than an approvable letter under Sec. 314.110) on 
the basis of draft labeling if the only deficiencies in the application 
concern editorial or similar minor deficiencies in the draft labeling. 
Such approval will be conditioned upon the applicant incorporating the 
specified labeling changes exactly as directed, and upon the applicant 
submitting to FDA a copy of the final printed labeling prior to 
marketing.
    (c) FDA will approve an application after it determines that the 
drug meets the statutory standards for safety and effectiveness, 
manufacturing and controls, and labeling, and an abbreviated application 
after it determines that the drug meets the statutory standards for 
manufacturing and controls, labeling, and, where applicable, 
bioequivalence. While the statutory standards apply to all drugs, the 
many kinds of drugs that are subject to the statutory standards and the 
wide range of uses for those drugs demand flexibility in applying the 
standards. Thus FDA is required to exercise its scientific judgment to 
determine the kind and quantity of data and information an applicant is 
required to provide for a particular drug to meet the statutory 
standards. FDA makes its views on drug products and

[[Page 142]]

classes of drugs available through guidance documents, recommendations, 
and other statements of policy.
    (d) FDA will approve an abbreviated new drug application and send 
the applicant an approval letter if none of the reasons in Sec. 314.127 
for refusing to approve the abbreviated new drug application applies. 
The approval becomes effective on the date of the issuance of the 
agency's approval letter unless the approval letter provides for a 
delayed effective date. An approval with a delayed effective date is 
tentative and does not become final until the effective date. A new drug 
product approved under this paragraph may not be introduced or delivered 
for introduction into interstate commerce until approval of the 
abbreviated new drug application is effective. Ordinarily, the effective 
date of approval will be stated in the approval letter.

[57 FR 17989, Apr. 28, 1992, as amended at 64 FR 402, Jan. 5, 1999; 65 
FR 56479, Sept. 19, 2000]