
Navigating Drug and Medical Device Legal Issues provides an authoritative, insider's perspective on assisting clients in dealing with legal concerns relating to the medical and pharmaceutical industry, including developing and trademarking brand names, complying with FDA regulations, and preventing or addressing claims of fraud. Featuring top partners from across the country, this book discusses the latest trends in the practice area, including the impact of the Affordable Care Act and recent Supreme Court decisions, such as Mississippi ex rel. Hood v. AU Optronics Corp. From quality standards to off-label uses, these experts consider the regulations governing drugs and medical supplies, and the degree to which they are being enforced. Additionally, these leaders discuss how the unique nature of software is handled in the area of medical law. 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 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. Frances M. Jagla, Partner, Lane Powell PC - "Navigating Trademark Issues in the Pharmaceutical Field"
2. Barry J. Siegel, Shareholder, and William A. Garvin, Counsel, Buchanan Ingersoll & Rooney PC - "Major Existing and Future Challenges to the Manufacturing, Promotion, and Sale of Drug and Device Products"
3. Peter A. Arhangelsky, Principal, Emord & Associates PC - "Key Concerns and Challenges for Medical Device Industry Clients"
4. Seth A. Mailhot, Michael Best & Friedrich LLP - "The Challenge of Software"
5. Amy S. Tingley, Shareholder, Stovash Case & Tingley PA - "Impacts of Federal Legislative Changes and Investigatory Trends on the Drug and Pharmaceutical Industry"
6. M. Gabrielle Hils, Partner, Dinsmore & Shohl LLP - "Defending Against the Onslaught of State Attorneys General Actions Against Drug Manufacturers: Lessons Learned From Recent Cases"
7. Jeffrey R. Lilly, Partner, Gordon & Rees LLP - "Fraud on the Market"
8. James A. Robertson and Walter F. Timpone, Partners, McElroy Deutsch Mulvaney, & Carpenter LLP, and Matt Allegrucci, Vice President of Ethics & Compliance Officer, Daiichi Sankyo Inc. - "Compliance Issues for Pharmaceutical and Medical Device Manufacturers"
About: Navigating Drug and Medical Device Legal Issues provides an authoritative, insider's perspective on assisting clients in dealing with legal concerns relating to the medical and pharmaceutical industry, including developing and trademarking brand names, complying with FDA regulations, and preventing or addressing claims of fraud.
Pricing is shown for items sent to or within the U.S., excluding shipping and tax. Please consult the store to determine exact fees. No warranties are made express or implied about the accuracy, timeliness, merit, or value of the information provided. Information subject to change without notice. isbn.nu is not a bookseller, just an information source.