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Recent Developments in Food and Drug Law, 2013 ed.: Leading Lawyers on Dealing with Increased Enforcement, Keeping Up-To-Date with FDA Requirements, ... Compliance Practices (Inside the Minds)
Recent Developments in Food and Drug Law provides an authoritative, insider's perspective on counseling clients on the evolution of pharmaceutical and labeling regulations. Featuring experienced partners from law firms across the nation, these experts guide the reader through the process of learning to prevent inspection problems and understanding the...
Recent Developments in Food and Drug Law provides an authoritative, insider's perspective on counseling clients on the evolution of pharmaceutical and labeling regulations. Featuring experienced partners from law firms across the nation, these experts guide the reader through the process of learning to prevent inspection problems and understanding the consequences of noncompliance with FDA regulations. These top lawyers offer specific advice on managing the financial risks of food and drug law fluctuations, inspections, biosimilar manufacturing, and patent and labeling litigation. From understanding pharmaceutical issues to the Food Safety and Modernization Act, these experts discuss the publicity of company documentation and the risks of promoting mislabeled goods. The different niches represented and the breadth of perspectives presented enable readers to get inside some of the great legal minds of today, as these experienced lawyers offer up their thoughts on the keys to success within this ever-changing field. Inside the Minds provides readers with proven business and legal intelligence from leading C-Level executives and lawyers. Each chapter offers thought leadership and expert analysis on an industry, profession, or topic, providing a future-oriented perspective and proven strategies for success. Each author has been selected based on their experience and C-Level standing within the business and legal communities. Chapters Include: 1. Sarah Brew, Partner, Faegre Baker Daniels LLP - "Food Law in Flux: Compliance and Risk Management Strategies to Address Food Safety Modernization Act Regulations and Food Labeling Litigation" 2. Jonathan M. Cohen, Partner, Gilbert LLP - "Managing the Financial Risks of Changes in the Regulation of Food Manufacturing and Distribution." 3. Lynn C. Tyler, Partner and Chair, Food, Drug, and Device Law Practice Group, Barnes & Thornburg LLP - "The FDA's Regulation of Off-Label Promotion: Has the Supreme Court's Opinion in Sorrell VS. IMS Health Cracked the Foundation?" 4. James F. Neale, Partner, McGuireWoods LLP - "Coping with the Rapidly Expanding Food and Drug Laws" 5. Brian J. Malkin, Partner, Frommer Lawrence & Haug LLP - "Challenges to the Development of a Biosimilars Industry in the United States" 6. Andrew S. Ittleman, Founding Partner, and Mitchell S. Fuerst, Founding Member, Fuerst Ittleman David & Joseph PL - "The FDA's Regulation of Autologous Stem Cell Therapies." 7. Anthony T. Pavel and Robert G. Hibbert, Partners, Morgan Lewis & Brockius LLP - "Food Claims Litigation: Seller Beware." 8. Michael J. O'Flaherty, Principal, Olsson Frank Weeda Terman Matz PC - "Consumer Litigation: A Growing Enforcement Concern for Food Labeling." 9. Michael A. Walsh, Partner, Strasberger & Price LLP - "The FDA and the First Amendment: Off-Label Promotion, Due Process, and the Commercial Speech Doctrine." 10. Nathan A. Beaver, Partner, Foley & Lardner LLP - " 'Natural' Claims: the Current Legal and Regulatory Landscape."
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