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By Jeffrey K. Shapiro – FDA has enhanced authority over the sale, distribution and use of devices that the agency designates as “restricted.” 21 U.S.C. § 360j(e). FDA almost always…
…delay the tax (see here). In the U.S. House, Rep. Erick Paulsen already sponsored a repeal measure (H.R. 436). Rep. Paulsen’s bill passed the House in June, but was stalled…
…. is fundamentally inconsistent with the agency’s previous decision to require Cumberland to undertake the postmarketing study of Acetadote® . . . and is thus, arbitrary and capricious.” Finally, Cumberland…
…Medtronic, Inc., 496 U.S. 661 (1990) and Merck KGaA v. Integra Lifesciences, Ltd., 545 U.S. 193 (2005). In those cases, the U.S. Supreme Court ruled that 35 U.S.C. § 271(e)(1)…
…restrictions would be interpreted by the courts to apply to all processed foods regardless of whether they are genetically engineered. (Emphasis in original). In relevant part, the text of the…
…who may bring an action for injunctive relief. In 2011, R. Brown et al. filed a complaint against The Hain Celestial Group, Inc. (“Hain”), claiming that Hain sold organic cosmetics…
…for introduction into interstate commerce. FDCA § 301(a). In addition, FDA has statutory jurisdiction over products that have been shipped in interstate commerce and thereafter become adulterated. FDCA § 301(k)….
…24, Rep. John Carter (R-TX) introduced the Common Sense Nutrition Disclosure Act of 2012 (H.R. 6174) to amend the menu labeling provisions. The amendment would allow delivery and take-out restaurants…
…sell or market prescription drugs or medical devices in Massachusetts (see our blog post here). See generally, Mass. Gen. Laws ch. 111N. The original law prohibited a company from providing…
…application number.” 21 C.F.R. § 314.54(a)(1)(iii) (emphasis added). FDA’s regulations (21 C.F.R. § 314.3) further define the term “listed drug” to mean: a new drug product that has an effective…
Hyman, Phelps & McNamara, P.C. Director Douglas B. Farquhar is a key presenter at the Food and Drug Law Institute’s (“FDLI’s”) upcoming conference in São Paulo, Brazil. The conference, which…
…intended use. Government’s Brief at 28-29. (Emphases in original.) HPM previously submitted comments to FDA on the Draft Guidance on August 30, 2011, and supplemental comments on September 22, 2011….
…“Requirements within the scope of this [Act] . . . which are in addition to, or different than those made under this [Act] may not be imposed by any State.” …
…That estimate was updated to reflect the passage of the Affordable Care Act. Chairman Leibowitz’s Politico piece drew sharp criticism from another FTC Commissioner, J. Thomas Rosch. In a response…
…grandfathering claim unless the FDA has engaged in “final agency action” under the APA. . . . Cody’s failure to avail itself of available administrative remedies [(i.e., use of the…