United States Code
USC most recently checked for updates: Dec 10, 2022
A conditionally approved new animal drug application may not be amended or supplemented to add indications for use.
The decision of the Secretary under subsection (c), (d), or (e) of this section refusing or withdrawing conditional approval of an application shall constitute final agency action subject to judicial review.
In this section and section 360ccc–1 of this title, the term “transgenic animal” means an animal whose genome contains a nucleotide sequence that has been intentionally modified in vitro, and the progeny of such an animal; Provided that the term “transgenic animal” does not include an animal of which the nucleotide sequence of the genome has been modified solely by selective breeding.