C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER A—GENERAL › PART 12—FORMAL EVIDENTIARY PUBLIC HEARING › Subpart A—General Provisions

21 C.F.R. § 12.1

Scope

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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.

Notes of Decisions
Cited in 2 cases, 2003–2003 · leading case: Warner-Lambert Co. v. Mills
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Warner-Lambert Co. v. Mills (2003) texapp · cites it 2× “§ 355 (e)(3); 21 C.F.R. § 12.1 et seq. Subchapter III of the Act contains extensive policing provisions available to the FDA, includes a list of prohibited acts with accompanying civil and criminal penalties applicable to both individual and corporate violators, and provides for…”
Warner-Lambert Company, Pfizer, Inc., Bayer Corporation, Del Pharmaceuticals, Inc., Del Laboratories, Inc. and Care Tech (2003) texapp “§ 355 (e)(3); 21 C.F.R. § 12.1 et seq . Subchapter III of the Act contains extensive policing provisions available to the FDA, includes a list of prohibited acts with accompanying civil and criminal penalties applicable to both individual and corporate violators, and provides…”
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