21 C.F.R. § 314.99 Other responsibilities of an applicant of an abbreviated application.
Title 21 - Food and Drugs
(a) An applicant shall comply with the requirements of §314.65 regarding withdrawal by the applicant of an unapproved abbreviated application and §314.72 regarding a change in ownership of an abbreviated application. (b) An applicant may ask FDA to waive under this section any requirement that applies to the applicant under §§314.92 through 314.99. The applicant shall comply with the requirements for a waiver under §314.90.
Title 21: Food and Drugs
PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
Subpart C—Abbreviated Applications
§ 314.99 Other responsibilities of an applicant of an abbreviated application.
