21 C.F.R. § 314.96 Amendments to an unapproved abbreviated application.
Title 21 - Food and Drugs
(a) Abbreviated new drug application. (1) An applicant may amend an abbreviated new drug application that is submitted under §314.94, but not yet approved, to revise existing information or provide additional information. (2) Submission of an amendment containing significant data or information constitutes an agreement between FDA and the applicant to extend the review period only for the time necessary to review the significant data or information and for no more than 180 days. (3) Submission of an amendment containing significant data or information to resolve deficiencies in the application as set forth in a not approvable letter issued under §314.120 constitutes an agreement between FDA and the applicant under section 505(j)(4)(A) of the act to extend the date by which the agency is required to reach a decision on the abbreviated new drug application only for the time necessary to review the significant data or information and for no more than 180 days. (b) The applicant shall submit a field copy of each amendment to §314.94(a)(9). 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. [57 FR 17983, Apr. 28, 1992, as amended at 58 FR 47352, Sept. 8, 1993; 64 FR 401, Jan. 5, 1999]
Title 21: Food and Drugs
PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
Subpart C—Abbreviated Applications
§ 314.96 Amendments to an unapproved abbreviated application.
