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Health Care and Life Sciences Law 2013
Karen S. Lovitch, Scott D. Danzis
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Table of Contents
Table of Contents
Chapter 1. Draft Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications (July 21, 2011)
Chapter 2. Rethinking the FDA’s Regulation of Mobile Medical Apps
Chapter 3. FDA Issues Draft Guidance Regarding Research Use Only and Investigational Use Only in Vitro Diagnostic Products (June 13, 2011)
Chapter 4. CMS Publishes Final Sunshine Act Rule Creating New Regulatory Landscape for Physician-Manufacturer Interactions
Chapter 5. Second Circuit Recognizes Significant First Amendment Protections for Off-Label Promotion
Chapter 6. Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information about Prescription Drugs and Medical Devices (December 2011)
Chapter 7. Case Analysis: The Sixth Circuit Reinforces the Holding that Only Violations of Conditions of Payment, Not Merely Conditions of Participation, Can be the Basis of a False Claims Act Action
Chapter 8. Practice Analysis: The Anticipated Impact of the Growing State FCA Trend on Businessess
Chapter 9. Health Care Sector: FCA Health Care Enforcement is White Hot
Chapter 10. Health Care Industry Current Developments: Thirty Thousand Foot View of Accountable Care Organizations and Clinical Integration
Chapter 11. Current Legal Issues Affecting the Practice of Telemedicine (July 26, 2013)
Chapter 12. Five Takeaways from the OIG’s Special Advisory Bulletin on Exclusion
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