[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR314.60]

[Page 114]
 
                        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 B--Applications
 
Sec. 314.60  Amendments to an unapproved application.

    (a) Except as provided in paragraph (b) of this section, the 
applicant may submit an amendment to an application that is filed under 
Sec. 314.100, but not yet approved. The submission of a major amendment 
(for example, an amendment that contains significant new data from a 
previously unreported study or detailed newnalyses of previously 
submitted data), whether on the applicant's own initiative or at the 
invitation of the agency, constitutes an agreement by the applicant 
under section 505(c) of the act to extend the date by which the agency 
is required to reach a decision on the application. Ordinarily, the 
agency will extend the review period for a major amendment but only for 
the time necessary to review the new information. However, the agency 
may not extend the review period more than 180 days. If the agency 
extends the review period for the application, the director of the 
division responsible for reviewing the application will notify the 
applicant of the length of the extension. The submission of an amendment 
that is not a major amendment will not extend the review period. An 
amendment that contains new clinical data from a previously unreported 
study shall contain a financial certification or disclosure statement or 
both as required by part 54 of this chapter, or FDA may refuse to accept 
any such amendment.
    (b)(1) An unapproved application may not be amended if all of the 
following conditions apply:
    (i) The unapproved application is for a drug for which a previous 
application has been approved and granted a period of exclusivity in 
accordance with section 505(c)(3)(D)(ii) of the act that has not 
expired;
    (ii) The applicant seeks to amend the unapproved application to 
include a published report of an investigation that was conducted or 
sponsored by the applicant entitled to exclusivity for the drug;
    (iii) The applicant has not obtained a right of reference to the 
investigation described in paragraph (b)(1)(ii) of this section; and
    (iv) The report of the investigation described in paragraph 
(b)(1)(ii) of this section would be essential to the approval of the 
unapproved application.
    (2) The submission of an amendment described in paragraph (b)(1) of 
this section will cause the unapproved application to be deemed to be 
withdrawn by the applicant under Sec. 314.65 on the date of receipt by 
FDA of the amendment. The amendment will be considered a resubmission of 
the application, which may not be accepted except as provided in 
accordance with section 505(c)(3)(D)(ii) of the act.
    (c) The applicant shall submit a field copy of each amendment to 
Sec. 314.50(d)(1). The applicant, other than a foreign applicant, shall 
include in its submission of each such amendment to FDA a statement 
certifying that a field copy of the amendment has been sent to the 
applicant's home FDA district office.

[50 FR 7493, Feb. 22, 1985, as amended at 57 FR 17983, Apr. 28, 1992; 58 
FR 47352, Sept. 8, 1993; 63 FR 5252, Feb. 2, 1998]