[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: 21CFR314.60]

[Page 105-106]
 
                        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

[[Page 106]]

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]