Part 16 — Regulatory Hearing Before the Food and Drug Administration
Current through Sep 8, 2026
Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.
Source: 44 FR 22367, Apr. 13, 1979, unless otherwise noted.
Sections
- § 16.1 Scope.
- § 16.5 Inapplicability and limited applicability.
- § 16.22 Initiation of regulatory hearing.
- § 16.24 Regulatory hearing required by the act or a regulation.
- § 16.26 Denial of hearing and summary decision.
- § 16.40 Commissioner.
- § 16.42 Presiding officer.
- § 16.44 Communication to presiding officer and Commissioner.
- § 16.60 Hearing procedure.
- § 16.62 Right to counsel.
- § 16.80 Administrative record of a regulatory hearing.
- § 16.85 Examination of administrative record.
- § 16.95 Administrative decision and record for decision.
- § 16.119 Reconsideration and stay of action.
- § 16.120 Judicial review.