investigational submission

Defined in 1 place of the United States Code.

The terms “investigational submission for a generic new animal drug” and “investigational submission” mean—

(A) the filing of a claim for an investigational exemption under section 360b(j) of this title for a generic new animal drug intended to be the subject of an abbreviated application or a supplemental abbreviated application; or

(B) the submission of information for the purpose of enabling the Secretary to evaluate the safety or effectiveness of a generic new animal drug in the event of the filing of an abbreviated application or supplemental abbreviated application for such drug.

Source

2008–present 21 U.S.C. § 379j-21Food and Drugs · Authority to assess and use generic new animal drug fees · in this section