supplemental animal drug application
Defined in 1 place of the United States Code.
The term “supplemental animal drug application” means—
(A) a request to the Secretary to approve a change in an animal drug application which has been approved; or
(B) a request to the Secretary to approve a change to an application approved under section 360b(c)(2) of this title for which data with respect to safety or effectiveness are required.
Source
- 2003–present21 U.S.C. § 379JFood and Drugs · Definitions · for purposes of this subpart