21 CFR 60.2 - Purpose.
(a) The purpose of this part is to establish a thorough yet efficient process for the Food and Drug Administration review of patent term restoration applications. To achieve this purpose, the regulations are intended to:
(1) Facilitate determinations of patent term restoration eligibility and regulatory review period length, and
(2) Ensure that parties interested in due diligence challenges will have an opportunity to participate in that process, including informal hearings.
Title 21 published on 2014-04-01
no entries appear in the Federal Register after this date.