supplement
Defined in 2 places of the United States Code.
The term “supplement” means a request to the Secretary to approve a change in a biosimilar biological product application which has been approved, including a supplement requesting that the Secretary determine that the biosimilar biological product meets the standards for interchangeability described in section 262(k)(4) of title 42.
Source
- 2012–present21 U.S.C. § 379j-51Food and Drugs · Definitions · for purposes of this subpart
The term “supplement” means a request to the Secretary to approve a change in a human drug application which has been approved.
Source
- 1994–present21 U.S.C. § 379GFood and Drugs · Definitions · for purposes of this subpart