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…Impax had to agree to a no-payment settlement . . . cannot undermine the Commission’s finding that a less restrictive settlement was viable.” Because evidence supported a reasonable factfinder to…
…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….
…to participate in the process. A second iteration of PFDD is bound to be a hot topic. *Admitted only in Maryland. Work supervised by the Firm while D.C. application pending….
…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,…
…previous holdings in Valley Drug Co. v. Geneva Pharm., Inc., 344 F.3d 1294, 1296 (11th Cir. 2003), Schering-Plough Corp. v. FTC, 402 F.3d 1056 (11th Cir. 2005), and Andrx Pharmaceuticals,…
…(E.D. Pa. 2008) (here); Merck & Cie v. Watson Pharms., Inc., C.A. No. 12-161-RGA (D. Del. Sept. 25, 2012) (here); and Otsuka Pharm. Co. v. Par Pharm., Inc., C.A. No….
By Jeffrey N. Wasserstein & William T. Koustas – On November 12, 2008, Senate Finance Committee Chairman Max Baucus released a white paper detailing what he sees as the substantial…
…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…
…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…
…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….
…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…
…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…
…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…
…this pandemic . . . let alone any future ones that may arise. The list below is anything but exhaustive, but we believe it includes the key areas for improvement….