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…Mylan Pharmaceuticals, Inc. v. Thompson, 268 F. 3d 1323 (Fed. Cir 2001), in which the Federal Circuit held in a pre-MMA case that an action for Orange Book patent delisting…
…could figure out how to comply. FDA originally set the PMTA deadline as August 8, 2022, but a district court in Maryland ordered FDA to shorten it. FDA complied with…
…27 (D.D.C. 2001) (here) . . . and that case didn’t turn out too well for FDA. (Of course, there was the initial case of National Pharmaceutical Alliance v. Henney,…
…(Docket No. FDA-2011-A-0363), submitted on behalf of Forest Laboratories, Inc. (“Forest”) (and with respect to a drug product under an NDA – NDA No. 202-450 – that apparently has not…
…studies were funded by industry. USRTK alleges that Coco-Cola Co. and PepsiCo Inc. are aware of these studies but continue to (fraudulently) use the term diet. Petitioners request that FDA…
…manufacturers regarding unauthorized nutrient content and health claims appearing in food labeling. In addition, some companies were cited for making certain claims that caused their foods to be drugs. For…
…priopionate and tazarotene) lotion. Of interest (to me) is the DTC communication cited where OPDP, again, focuses on a video and alleges false or misleading representations regarding risks and efficacy….
…FDA’s authority may intersect with the practice of medicine. Gomperts v. Azar et al., 1:19-cv-003450DCN (D. Idaho Sept. 9, 2019). At the outset, we note that this case is centered…
…these products, which was completed in 2005. A guidance document cannot alter a regulation, but can clarify how FDA intends to enforce the regulation. In a self-described balancing act, Commissioner…
…within 20 days, but refused to provide any information on the manufacturing process as required under 42 U.S.C. § 262(l)(2)(A). This action comes after Amgen Inc. v. Sandoz, in which…
…all its components . . . or (ii) [t]he end product is a [commercially available off-the-shelf (“COTS”)] item.” Id. 25.003. A COTS item is a commercial item (which is an…
…government agencies, including FDA, it does not speak for all federal agencies (e.g., SEC). Foreign regulators and state and local enforcement agencies must buy into DOJ policy for true effectiveness….
…the FTC. The case against Kochava is a little different. The complaint does not describe deceptive practices, instead alleging that Kochava was acting unfairly. According to the FTC and DOJ,…
…to allow Americans to buy safe and effective drugs from other countries . . . .” This cryptic statement appears to refer to the importation of finished pharmaceuticals, though the…
By Susan J. Matthees – Last week FDA published a memorandum titled “FDA Comments on Symbols Public Hearing and Current Plans for Addressing Issues.” The memorandum responds to questions and…