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ISBN:9780314279637

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简介

Recent Developments in Food and Drug Law provides an authoritative, insider's perspective on complying with FDA regulations and staying up-to-date on the latest trends in food and drug law. Featuring partners from some of the nation's leading law firms, these experts guide the reader through the process of communicating changes in enforcement and discuss tips on establishing successful compliance plans. These top lawyers offer their advice for collaborating with government agencies, managing potential risks, and responding to investigations. From medical devices to food and dietary supplements, these authors discuss company best practices for anticipating and overcoming compliance challenges. Upcoming trends, such as the increased use of information technology in the field, are also explored. 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 around the keys to success within this increasingly enforced area of law. 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. Brian E. Dickerson, Partner, Roetzel & Andress LPA, "Staying in Compliance with the New Food and Drug Laws in a Changing Legal Environment" 2. Eric D. Hargan, Shareholder, Greenberg Traurig LLP, "The Internet, Information Technology, and the FDA" 3. John E. Villafranco, Partner, Kelley Drye & Warren LLP, "New Standards, Heightened Enforcement, and Increased Litigation: Managing the New Legal Risks Facing Food and Dietary Supplement Companies" 4. Catherine M. Dickenson, Partner, Husch Blackwell LLP, "Issues and Trends in Drug Product Labeling" 5. Vernessa T. Pollard, Partner, Arnold & Porter LLP, and Chandra Branham, Vice President of Payment and Health Care Delivery Policy, Advanced Medical Technology Association (AdvaMed), "FDA Medical Device Requirements: A Legal Framework for Regulating Health Information Technology, Software, and Mobile Apps" 6. James N. Czaban, Partner, Wiley Rein LLP, "Meeting the Challenge of Increased Enforcement for Food and Drug Industry Clients" 7. Peter Quinter, Shareholder, Becker & Poliakoff PA, "New Enforcement/Compliance Challenges for Food and Drug Industry Clients" 8. Verne A. Luckow, Member, Polster Lieder Woodruff & Lucchesi LC, "Complex Interactions Between FDA and PTO Regulations Affecting Exclusivity Periods and the Patent Term of Biopharmaceutical Drug Products"

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