21 C.F.R. § 314.97 Supplements and other changes to an approved abbreviated application.
Title 21 - Food and Drugs
The applicant shall comply with the requirements of §§314.70 and 314.71 regarding the submission of supplemental applications and other changes to an approved abbreviated application.
Title 21: Food and Drugs
PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
Subpart C—Abbreviated Applications
§ 314.97 Supplements and other changes to an approved abbreviated application.
