Working with Government Agencies in Food and Drug Law: Leading Lawyers on Building Relationships with Government Agencies and Representing Clients in Enforcement Proceedings

Working with Government Agencies in Food and Drug Law is an authoritative, insider's perspective on best practices for advising clients on overcoming violations and resolving compliance issues enforced by government agencies. Featuring partners from some of the nation s leading law firms, these experts guide the reader through the effects of the emerging regulatory environment, and the new political issues surrounding food and drug law enforcement. These top lawyers reveal their advice on establishing a positive relationship between clients and agencies, understanding misconceptions clients have about regulators and vice versa, representing clients being investigated for potential violations or non-compliance, and navigating recent developments in food and drug case law. Additionally, these leaders discuss how to manage client expectations, outline the benefits of compliance, and describe the lawyer's role in a government investigation. 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. Mitchell Fuerst and Christine Humphrey, Partners, Fuerst Humphrey Ittleman PL - "Assisting and Defending Clients in Overcoming Violations and Resolving Compliance Situations"
2. Christopher L. Hagenbush, Partner, Patton Boggs LLP Compliance Issues and Challenges for Food and Drug Industry Clients
3. Mark C. Levy, Partner, Saul Ewing LLP - "Defending a Pharmaceutical, Medical Device, or Biotechnology Client in a Government Investigation: Key Issues for Clients and Attorneys"
4. Heather E.A. Watts, Partner, Deeth Williams Wall LLP - "Canadian Food and Drug Law Enforcement Trends and Issues"
5. Claudia Lewis-Eng, Partner, Venable LLP - "Working Amicably with the FDA"

Appendices Include:

Appendix A: Summary of Laws Enforced by the FDA
Appendix B: FDA Guide to Self-Inspection
Appendix C: FDA Compliance Program Guidance Manual Information
Appendix D: FDA Issues Good Reprint Practices Guidance