United States v. Undetermined Quantities of Various Articles of Drug ... Equidantin Nitrofurantoin Suspension’s Empirical Analysis
675 F.2d 994 · 1982
Citation profile
6 federal appellate · 2 district ·
Relationships
Relies on O’Callahan v. Parker, Warden · United States v. Security Industrial Bank · Weinberger v. Hynson, Westcott & Dunning, Inc. · Logan v. Zimmerman Brush Co. · Weinberger v. Bentex Pharmaceuticals, Inc.
Most-quoted passages
The sentences later courts lift from this opinion, ranked by how many decisions quote each — the parts of the opinion doing the work. These counts are smaller than the citation total above because most of the 11 citing decisions cite the case generally; a passage count includes only decisions quoting that exact language verbatim.
“Either a genuine dispute concerning the safety and effectiveness of a drug product or unawareness of the drug product among qualified experts precludes a finding of “general recognition” for purposes of ... 21 U.S.C. § 321 (w)____ Thus, “general recognition” among experts must be based upon “ ‘adequate and well-controlled investigations,’ ” as well as publication in scientific literature. “Anecdotal evidence,” i.e., testimony of physicians unsupported by controlled investigation or scientific publication, does not constitute “substantial evidence.” The mere fact that a drug product has been marketed for an extended period does not preclude a finding of “new drug” status.”
1 later decision quote this exact passage · from the majority“The term “new animal drug” means any drug intended for use for animals other than man, including any drug intended for use in animal feed but not including such animal feed,— (1) The composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof.”
1 later decision quote this exact passage · from the majority“the rate and extent to which the active drug ingredient or therapeutic moiety is absorbed from a drug product and becomes available at the site of drug action.”
1 later decision quote this exact passage · from the majority
How this case has been treated — in progress
Whether each later court followed, distinguished, criticized, or overruled this decision. The treatment classification (task #35) runs highest-cited cases first and lights up here as it reaches this one.