Review by the courts.

21 C.F.R. § 12.140
in effectEffective: 2024-07-01
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(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.

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