substantially complete application
Defined in 1 place of the United States Code.
As used in this subsection, the term “substantially complete application” means an application under this subsection that on its face is sufficiently complete to permit a substantive review and contains all the information required by paragraph (2)(A).
Source
- 2013–present21 U.S.C. § 355Food and Drugs · New drugs · under this section
Substantially complete application.—As used in this subsection, the term "substantially complete application" means an application under this subsection that on its face is sufficiently complete to permit a substantive review and contains all the information required by paragraph (2)(A).
Source
- 2003–202321 U.S.C. § 355Food and Drugs · New drugs · under this section