21 CFR 12.140 - Review by the courts.
(a) The Commissioner's final decision constitutes final agency action from which a participant may petition for judicial review under the statutes governing the matter involved. Before requesting an order from a court for a stay of action pending review, a participant shall first submit a petition for a stay of action under § 10.35.
(b) Under 28 U.S.C. 2112(a), FDA will request consolidation of all petitions related to a particular matter.