Life Sciences 2016: Navigating Legal Challenges in the Drug and Device Industries

Front Matter
Faculty Bios
Table of Contents
Chapter 1. Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Public Hearing; Request for Comments, Department of Health and Human Services, Food and Drug Administration, 21 CFR Part 15 (September 1, 2016)
Chapter 2. FDA Publishes Two Draft Guidances on Next Generation Sequencing Technology (July 18, 2016)
Chapter 3. FDA Publishes Draft Guidance on Codevelopment of Companion Diagnostics (August 2, 2016)
Chapter 4. Amarin Pharma, Inc., Dr. Jonathan Herbst, Dr. Eric Rishe, Dr. Peter Gottesfeld, and Dr. Ralph Yung v. United States Food & Drug Administration, United States of America, Stephen Ostroff, M.D., and Sylvia Matthews Burwell, Case 1:15-cv-03588-PAE (S.D.N.Y. 2015)
Chapter 5. Pacira Pharmaceuticals, Inc., Dr. Loren J. Harris, and Dr. Joseph W. Bell v. United States Food & Drug Administration; United States of America; Dr. Stephen Ostroff, United States Department of Health & Human Services, and Sylvia Mathews Burwell, Stipulation and Order, Case 1:15-cv-07055-LAK (S.D.N.Y. 2015)
Chapter 6. Memo to The Honorable Sylvia Burwell from Committee on Energy and Commerce (May 26, 2016)
Chapter 7. Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Product (Draft Guidance) (January 2015)
Chapter 8. Guidance for Industry and FDA Staff: Classification of Products as Drugs and Devices & Additional Product Classification Issues (Draft Guidance) (June 2011)
Chapter 9. Draft Guidance for Industry and Food and Drug Administration Staff: Medical Device Reporting for Manufacturers (Draft Guidance) (July 9, 2013)
Chapter 10. Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients (Minority Staff Report) (January 2016)
Chapter 11. Medicaid Drug Rebate Program Notice for Participating Drug Manufacturers (July 14, 2016)
Chapter 12. Medicare Program; Part B Drug Payment Model; Proposed Rule, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 42 CFR Part 511 (March 2016)
Chapter 13. Notice of Proposed Rulemaking for Bundled Payment Models for High-Quality, Coordinated Cardiac and Hip Fracture Care (July 25, 2016)
Chapter 14. Medicare Clinical Diagnostic Laboratory Tests Payment System Final Rule (June 17, 2016)
Chapter 15. Anti-Corruption Enforcement: What to Watch in 2016 (Winter 2016)
Chapter 16. Mitigating FCPA Risk: The Critical Role of Due Diligence in M&A and Joint Ventures
Chapter 17. Specific FDA Enforcement Tools
Chapter 18. The Foreign Corrupt Practices Act and Its Impact on the Pharmaceutical Industry
Chapter 19. Huge Stark Law Hospital Settlements and Physician Culpability—The New Normal Post-Tuomey?
Chapter 20. Effective Compliance Programs and Investigations (PowerPoint slides)
Chapter 21. Effective Compliance Programs: Ensuring Your Client is Protected/Internal Investigations: A Hypothetical
Chapter 22. Department of Health and Human Services, Office of Inspector General, OIG Compliance Program Guidance for Pharmaceutical Manufacturers
Chapter 23. Practical Guidance for Health Care Governing Boards on Compliance Oversight
Chapter 24. The Health Care Industry and DOJ’s New Corporate Conduct Enforcement Guidelines
Index