By Carrie S. Martin –       On November 19, the Washington Legal Foundation (“WLF”), along with three other organizations, filed an amicus curiae brief in support of Allergan, Inc.’s First Amendment…

…dairy farms alleged to market cows bearing unlawful drug residues. Although nominally a veterinary drug case, the court’s decision offers a number of gems of general interest. Defendants operate three…

…an initial inventory of all stocks on-hand on or before January 11, 2012 and then include carisoprodol in its biennial inventory thereafter; f.  Registrants who possess any quantity of carisoprodol…

…former Merck employee and a Louisiana physician under the Federal False Claims Act (“FCA”) and state false claims laws.  The FCA allows for private individuals to file a qui tam…

…largely from civil cases filed under seal under the federal False Claims Act, 31 U.S.C. § 3029 et. seq. (“FCA”). The cases are typically brought by one or more individuals…

…or misleading commercial advertising.  The Court held that Defendants’ claims were false because the Defendants did not perform clinical studies and did not test the actual product; instead the Court…

By Wes Siegner – Does meeting the FTC legal standard for claim substantiation protect claims from action by the National Advertising Division (“NAD”)?  If you think the answer should be…

…magnesium, and valganciclovir hydrochloride), and that FDA immediately approve all tentatively approved ANDAs for these drugs and any other tentatively approved drugs for which final approval is blocked by Ranbaxy’s…

…contract pharmacy arrangements Hospital eligibility criteria Eligibility of off-site facilities That rule – which has come to be known as the “mega-rule,” is currently under review by the Office of…

…in DOJ’s Civil Division).  To close out the conference, HP&M’s Ricardo Carvajal will moderate a session on the business aspects of food safety.  More information on the agenda and registration is…

…immediately.  The delay in Ranbaxy approval to market esomeprazole has created a bottleneck preventing other potential generic drug entrants from obtaining final approval of their [ANDAs] and beginning to sell…

…the statutes were satisfied and where, unless Apotex can obtain the declaratory judgment sought in this action, final FDA approval of its [ANDA] will be delayed by at least 180…

More than 40 registrants — primarily hospitals and pharmacies — have paid significant civil penalties of up to $5,000,000 to settle allegations they failed to report controlled substance thefts or…

…that were originally intended to be included in the mega-rule – i.e., the definition of an eligible patient; compliance requirements for contract pharmacy arrangements; hospital eligibility criteria; and eligibility of…

…and related to an alleged violation of the anti-kickback statute, the False Claims Act, the Federal Food, Drug, and Cosmetic Act, or any other federal civil or criminal law.  This…