Objectives â¢ New drug approval process â¢ Pricing of new drugs â¢ Off ...

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3/15/13% On December 3, 2012, a divided Second Circuit held in United States v. Caronia (“Caronia”) that the misbranding provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) do not criminalize “the truthful off-label promotion of FDA-approved prescription drugs.” The two-judge majority based its holding primarily on last year’s Supreme Court decision in Sorrell v. IMS Health, Inc., which held that “[s]peech in aid of pharmaceutical marketing…is a form of expression protected by the Free Speech Clause of the First Amendment.” http://www.jdsupra.com/legalnews/off-label-marketing-questioned-as-a-viab-49267/ 20%
3/15/13% lipidrescue.squarespace.com Controlled Animal Studies: Effect of IV Lipid Emulsion DRUG POSITIVE N.S. Bupivacaine 4 3 * Thiopental 2 0 Verapamil 5 1 Nifedipine 0 1 Propranolol 1 2 Atenolol 0 1 Metoprolol 0 1 Amitriptyline 0 1 Clomipramine 5 0 Jamaty C et al: Lipid emulsions in the treatment of acute poisoning. Clin Toxicol 2010; 48:1-27 21%
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Objectives â¢ New drug approval process â¢ Pricing of new drugs â¢ Off ...