Aspatore Books: Food and Drug Law Settlements and Negotiations: Leading Lawyers on Complying with Federal Regulations, Negotiating Contracts with Manufacturers and Suppliers, and Defending Clients in Products Liability Litigation (Inside the Minds)

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Food and Drug Law Settlements and Negotiations: Leading Lawyers on Complying with Federal Regulations, Negotiating Contracts with Manufacturers and Suppliers, and Defending Clients in Products Liability Litigation (Inside the Minds)

Author: Multiple Authors
Published Month: Sept 2006
Media: Paperback
Length: 316 pages
ISBN: 1596225963
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Description

Food and Drug Law Settlements and Negotiations is an authoritative, insider’s perspective on key strategies for representing food and drug companies before federal agencies and in business transactions. Featuring partners and shareholders from some of the nation’s leading firms, these experts guide the reader through the gamut of legal responsibilities of attorneys in this area, such as: avoiding mass tort litigation, creating compliant product labeling, negotiating food and drug law issues within corporate deals, and defending clients in patent infringement cases. These top lawyers give solid advice for everything from product development and regulatory compliance to effective product launch planning and the assessment of client financial liability. From common client mistakes to creating an effective negotiation strategy, these authors explain methods for guiding and protecting their clients throughout all phases of food and drug development and distribution. 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 ever-changing area of law.

Inside the Minds provides readers with proven business intelligence from C-Level executives (Chairman, CEO, CFO, CMO, Partner) from the world’s most respected companies nation-wide, rather than third-party accounts from unknown authors and analysts. Each chapter is comparable to an essay/thought leadership piece and is a future-oriented look at where an industry, profession, or topic is headed and the most important issues for the future. Through an exhaustive selection process, each author was hand-picked by the Inside the Minds editorial board to author a chapter.

Chapters Include:

1. Ivan J. Wasserman, Partner, Kelley Drye Collier Shannon - "An Overview of the Challenges We Face and How to Survive Them"

2. R. Mark McCareins, Capital Partner, Winston & Strawn LLP - "Reflections of an Intellectual Property and Antitrust Litigator on Pharmaceutical Disputes"

3. William H. Kitchens, Managing Partner, Arnall Golden Gregory LLP - "Tactical Approaches to Common Problems Affecting FDA-Regulated Companies"

4. Eric M. Kraus, Partner, Sedgwick, Detert, Moran & Arnold LLP - "Managing and Avoiding Mass Tort Litigation"

5. Robert E. Colletti, Partner, Frommer Lawrence & Haug LLP - "The Role of the Food and Drug Attorney in Hatch-Waxman Lawsuits"

6. Kathleen M. Sanzo, Partner and Practice Group Leader, FDA/Health Care Regulation Practice Group, Morgan Lewis - "Keys to Successful Interactions with Governing Bodies"

7. Mark S. Cheffo, Partner, Skadden, Arps, Slate, Meagher & Flom LLP - "Protecting the Client Against Current and Future Problems"

8. Martin R. Dix, Shareholder, Akerman Senterfitt - "Navigating the Pharmacy and Drug Law Requirements"

9. Robert F. Lewis, Shareholder, GrayRobinson PA - "Developing and Realizing the Client’s Business Goals"

Appendices:

Appendix A: Brief - Baxter Healthcare v. Abbott Laboratories, 315 F. 3d 829 (7th Cir. 2002)
Appendix B: Brief - Abbott Laboratories v. Baxter Healthcare, 334 F. 3d 1274 (Fed. Cir. 2003)
Appendix C: Clinical Study and Research Agreement
Appendix D: Standard Operating Procedure for Development, Review, and Approval of Promotional Material
Appendix E: Guidance for Industry: Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products—Content and Format
Appendix F: Memorandum of Law in Support of Motion for Judgment on Pleadings
Appendix G: Reply Memorandum of Law in Further Support of Motion for Judgment on Pleadings
Appendix H: OIG Safe Harbor and CMS Stark Exception for E-Prescribing and E-Recordkeeping Chart
Appendix I: Memorandum Regarding the Reviewing of Agreements for Anti-Kickback and Stark Law Purposes
Appendix J: Memorandum Regarding Co-Payments Due from Patients Covered by Private Third-Party Prescription Drug Programs