21 CFR 316.2 - Purpose.
The purpose of this part is to establish standards and procedures for determining eligibility for the benefits provided for in section 2 of the Orphan DrugAct, including written recommendations for investigations of orphan drugs, a 7-year period of exclusive marketing, and treatment use of investigational orphan drugs. This part is also intended to satisfy Congress' requirements that FDA promulgate procedures for the implementation of sections 525(a) and 526(a) of the act.
Title 21 published on 2015-12-03.
No entries appear in the Federal Register after this date, for 21 CFR Part 316.