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Recent Developments in Food and Drug Law: Leading Lawyers on Analyzing Recent Litigation, Navigating Increased Enforcement Efforts, and Complying with FDA Requirements (Inside the Minds)
Recent Developments in Food and Drug Law provides an authoritative, insider's perspective on key strategies for analyzing new rules and regulations in food and drug law. Featuring partners from some of the nation's leading law firms, these experts guide the reader through notable cases, statutory provisions, and enforcement policies that attorneys and...
Recent Developments in Food and Drug Law provides an authoritative, insider's perspective on key strategies for analyzing new rules and regulations in food and drug law. Featuring partners from some of the nation's leading law firms, these experts guide the reader through notable cases, statutory provisions, and enforcement policies that attorneys and their clients should be aware of. These top lawyers discuss the impact of the health care reform legislation on food and drug law and offer tips on how best to help clients comply with new regulations. From inspections and the issuance of warning letters to enforcement actions, these leaders reveal their advice on preparing clients for a significant increase in FDA policing activities. These authors explain how communicating with the FDA, educating clients, and conducting internal audits aid in securing the best results for clients. Additionally, this book predicts the continuation of congressional interest and legislative activity in the food and drug arena. 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 navigating this increasingly-enforced area of law. Inside the Minds provides readers with proven business intelligence from C-Level executives and lawyers (Chairman, CEO, CFO, CMO, Partner) from the world's most respected companies and firms nationwide. Each chapter is comparable to an essay/thought leadership piece and is a future-oriented look at where an industry, profession, or topic is heading and the most important issues for the future. Each author has been selected based upon their experience and C-level standing within the professional community. Chapters Include: 1. Julie Ann Dykstra, Of Counsel, Barnes & Thornburg LLP - "Protecting America's Health: Key Initiatives in Our Nation's Food and Drug Laws" 2. Diane Romza-Kutz, Partner and Team Leader, Life Sciences Team, Troutman Sanders LLP - "Ensuring Compliance with the New Food and Drug Law Regulations" 3. Frederick R. Ball, Partner, Duane Morris LLP - "Responding to New Food and Drug Case Law and Regulations" 4. Sheila D. Walcoff, Partner, McDermott Will & Emery LLP - "New Statutory Provisions, Litigation, and Enforcement Policy in FDA Law" Appendices Include: Appendix A: Margaret Hamburg Speech Appendix B: Sec. 4205 of Health Care Law Appendix C: Winston Labs v. FDA Appendix D: U.S. v. Park Appendix E: 68 Fed. Reg. 23731 Appendix F: Statement of Interest and Question Presented Appendix G: Association for Molecular Pathology v. United States Patent and Trademark Office Appendix H: EMEA Guidance Appendix I: FDA News Release Appendix J: Federal Register Notice of the Public Meeting on LDTs
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