…FDCA.  With respect to the other indicted individuals, the government dropped all charges against one, the one who proceeded to trial with Schulte was acquitted of all charges, and the…

…notice cannot be provided until at least FDA approval of a Section 351(k) application.  In making these allegations, Amgen asserted several causes of action, including unfair competition under Cal. Bus….

…to the U.S. Constitution. The Administrative Procedure Act:  The complaint alleges that the Final Guidance is arbitrary, capricious, and contrary to the TCA, and also exceeds FDA’s authority under the…

…wrongdoing and who can almost be said to have actually known the critical facts.’”  80 Fed. Reg. 28,672 (quoting Global-Tech Appliance, Inc., 131 S. Ct. at 2070-71).  The Administrator further…

…approved drugs violate the FDCA.  Id. at 9.  The court described FDA’s long-standing position that off-label promotion of drug products risks criminal misbranding under the FDCA.  FDCA § 301(b).  A…

…with their insurer. The OIG concluded that, although the arrangement has the potential to generate improper remuneration under the federal health care program anti-kickback statute (“AKS”), 42 U.S.C. § 1320a–7b(b),…

…is the latest attempt to pass legislation to address pharmaceutical patent settlement agreements (aka “reverse payment agreements” or “pay-for-delay agreements”).  It’s also the first attempt (that we can recall) that…

…the scope of the existing clearance or approval, opening the manufacturer up to criminal and civil liability for past sales and the burden of developing a new marketing application to…

…DEA may issue a final rule on electronic prescriptions (the agency issued an interim final rule on March 31, 2010) and a proposed rule on transporting controlled substances by ambulance,…

…that had her audience paying attention, even if they weren’t necessarily singing along. Of course, the traditional corporate enforcement chart-toppers were all there for the DAG. Prevent corporate wrongdoing before…

…practitioner compliance with federal and state corresponding responsibility requirements while ensuring that patients receive needed medical care.  Thirteen healthcare stakeholders, including NABP, the American Medical Association, Federation of State Medical…

…four synthetic cannabinoids in Schedule I: quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC); quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB-22; 5F-PB-22); N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA); and N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB-PINACA). Schedules of Controlled Substances: Temporary Placement of Four Synthetic Cannabinoids into…

…in another Illinois District Court Hatch-Waxman case involving generic FOSRENOL (lanthanum carbonate) 500 mg, 750 mg, and 1000 mg Chewable Tablets – Shire Canada Inc. v. Alkem Laboratories, Ltd., Case…

…a reference to potential legislation on the horizon, Senator Amy Klobuchar (D-MN), along with Sens. Chuck Grassley (R-IA), Dick Durbin (D-IL) and Al Franken (D-MN), introduced S. 214, the Preserve…

…be substantiated based on published research; companies do not need to perform their own clinical studies.  The Court also rejected other arguments by the FTC regarding other product claims.  For…