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Life Sciences 2017: Navigating Legal Challenges in the Drug and Device Industries

Chair(s): Scott D. Danzis, Nathan A. Brown

Practice Area: Life sciences, Medical devices, Pharmaceuticals, Regulation and compliance (Life sciences)

Published: Oct 2017 i Other versions can be found in the Related Items tab.
ISBN: 9781402429965
PLI Item #: 186818
CHB Spine #: M14

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Front Matter
Faculty Bios
Table of Contents
Chapter 1. FDA Offers Some Clarity (But Few Concessions) on Off-Label Communication of Medical Products (January 27, 2017)
Chapter 2. Senate Passes Long-Awaited FDA User Fee Package (August 4, 2017)
Chapter 3. The 21st Century Cures Medical Software Provisions: Additional Clarity for Digital Health, but Also More Questions (January 3, 2017)
Chapter 4. Digital Health Innovation Action Plan
Chapter 5. FDA Initiates Software Precertification Pilot Program (August 3, 2017)
Chapter 6. FDA Releases Details and Timelines in Its Digital Health Innovation Action Plan (August 3, 2017)
Chapter 7. H.R. 2430—115th Congress: FDA Reauthorization Act of 2017 (August 14, 2017)
Chapter 8. European Union
Chapter 9. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Chapter 10. Frequently Asked Questions, Protecting Access to Medicare Act (PAMA), CMS 1621 F, Medicare Program—Medicare Clinical Diagnostic Laboratory Tests Payment System Final Rule (March 9, 2017)
Chapter 11. Medicare Program; Medicare Clinical Diagnostic Laboratory Tests Payment System; Final Rule (June 23, 2016)
Chapter 12. Specific FDA Enforcement Tools
Chapter 13. Effective Compliance Programs and Investigations (November 2, 2016)
Chapter 14. Effective Compliance Programs: Ensuring Your Client Is Protected/Internal Investigations: A Hypothetical
Chapter 15. OIG Compliance Program Guidance for Pharmaceutical Manufacturers
Chapter 16. Practical Guidance for Health Care Governing Boards on Compliance Oversight
Index

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