21 U.S.C. § 335
Hearing before report of criminal violation
Before any violation of this chapter is reported by the Secretary to any United States attorney for institution of a criminal proceeding, the person against whom such proceeding is contemplated shall be given appropriate notice and an opportunity to present his views, either orally or in writing, with regard to such contemplated proceeding.
Notes of Decisions
Cited in 32
cases, 1942–2020 · leading case: People v. Frantz, 114 P.3d 34 (Colo. Ct. App. 2005).
People v. Frantz, 114 P.3d 34 (Colo. Ct. App. 2005). “s: Controlled substance analog does not mean a listed controlled substance; or a substance for which there is an approved drug application, so long as such substance is in its intended and unconverted form; or a substance with respect to which an exemption is in effect for…”
United States v. Gel Spice Co., Inc., 601 F. Supp. 1214 (E.D.N.Y 1985). “Three hearings were subsequently held pursuant to § 305 of the Act, 21 U.S.C. § 335 . Section 305 hearings afford a person against whom the FDA is contemplating a criminal prosecution “appropriate notice and an opportunity to present his views, either orally or in writing, with…”
United States v. Y. Hata & Co., Ltd., a Corp., United States of Am. v. Minoru Hata, 535 F.2d 508 (9th Cir. 1976). “We reject appellants’ contention that the government abused to such an extent the hearing process provided for in the Act [ 21 U.S.C. § 335 ], as to require dismissal of the indictment.”
United States v. David W. Prigmore, United States v. Lee H. Leichter, United States v. John F. Cvinar, 243 F.3d 1 (1st Cir. 2001). “Second, defendants Crinar and Prigmore contend that they are entitled to dismissal of the conspiracy charge because the FDA did not provide them with notice and an opportunity to present to the FDA their “views” as to the events underlying this case prior to reporting their…”
United States v. Kordel, 397 U.S. 1 (1970). “” 5 Section 305 of the Act, 21 U. S. C. § 335 , provides: “Before any violation of [the Act] .”
Fulgenzi v. Wyeth, Inc., 686 F. Supp. 2d 715 (N.D. Ohio 2010). “In support of its motion, the generic manufacturer maintains that Plaintiffs claims are conflict-preempted under 21 U.S.C. § 335© of the Food, Drug & Cosmetic Act, 21 C.”
Larry Leon Chaney v. Margaret M. Heckler, as Sec'y of Health & Human Servs., 718 F.2d 1174 (D.C. Cir. 1984). “See 21 U.S.C. § 335 . The opinion places its major reliance upon what it calls the FDA’s “Policy Statement,” the relevant portion of which is set forth at page 1186.”
United States v. Gel Spice Co., Inc. & Barry Engel, 773 F.2d 427 (2d Cir. 1985). “Where the possible legal action is criminal prosecution, the field office provides the potential defendants with an Opportunity to Present Views, pursuant to 21 U.S.C. § 335 , and 21 CFR 7.84 et seq.”
Hill Dermaceuticals, Inc. v. U.S. Food & Drug Admin., 826 F. Supp. 2d 252 (D.D.C. 2011). “21 U.S.C. § 335 (a), (b). The NDA must contain extensive scientific data and other information, including investigative reports demonstrating the drug’s safety and effectiveness, a statement of the drug’s components, and specimens of proposed labeling for the packaging of the…”
United States v. Goldberg, 538 F.3d 280 (3rd Cir. 2008). “administrative order, injunction, decree, or process” language with any “final agency action,” citing 21 U.S.C. § 335 , governing the F.D.C.A., which provides that “[bjefore any violation of this chapter is [referred] for institution of a criminal proceeding, the person against…”
United States v. St. Regis Paper Co., 355 F.2d 688 (2d Cir. 1966). “48 (1943) (relied on Morgan for similar construction of Section 305 of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 335 ). In United States v. Gris, 247 F.”
Helco Prods. Co. v. McNutt, 137 F.2d 681 (D.C. Cir. 1943). “7 21 U.S.C.A. § 335 : “Before any violation of this chapter is reported by the Administrator to any United States attorney for institution of a criminal proceeding, the person against whom such proceeding is contemplated shall be given appropriate notice and an opportunity to…”
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