21 C.F.R. § 12.1

Current through April 30, 2024

Section 12.1 - Scope

The procedures in this part apply when-

(a) A person has a right to an opportunity for a hearing under the laws specified in § 10.50 ; or

(b) The Commissioner concludes that it is in the public interest to hold a formal evidentiary public hearing on any matter before FDA.

21 C.F.R. §12.1