| Table of Contents |
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| Chapter 1: Draft Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications (July 21, 2011) |
Scott D. Danzis ~ Covington & Burling LLP
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| Chapter 2: Rethinking the FDA’s Regulation of Mobile Medical Apps |
Scott D. Danzis ~ Covington & Burling LLP
Christopher Pruitt ~ Covington & Burling LLP
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| Chapter 3: FDA Issues Draft Guidance Regarding Research Use Only and Investigational Use Only in Vitro Diagnostic Products (June 13, 2011) |
Ellen Flannery ~ Covington & Burling LLP
Scott D. Danzis ~ Covington & Burling LLP
Christopher Pruitt ~ Covington & Burling LLP
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| Chapter 4: CMS Publishes Final Sunshine Act Rule Creating New Regulatory Landscape for Physician-Manufacturer Interactions |
Karen Lovitch ~ Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
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| Chapter 5: Second Circuit Recognizes Significant First Amendment Protections for Off-Label Promotion |
Scott D. Danzis ~ Covington & Burling LLP
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| Chapter 6: Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information about Prescription Drugs and Medical Devices (December 2011) |
Scott D. Danzis ~ Covington & Burling LLP
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| 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 |
Timothy P. Mccormack ~ Phillips & Cohen LLP
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| Chapter 8: Practice Analysis: The Anticipated Impact of the Growing State FCA Trend on Businesses |
Laura Laemmle-Weidenfeld ~ Patton Boggs LLP
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| Chapter 9: Health Care Sector: FCA Health Care Enforcement is White Hot |
Timothy P. Mccormack ~ Phillips & Cohen LLP
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| Chapter 10: Health Care Industry Current Developments: Thirty Thousand Foot View of Accountable Care Organizations and Clinical Integration |
David F. Hendren ~ Augmentum Advisors, LLC
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| Chapter 11: Current Legal Issues Affecting the Practice of Telemedicine (July 26, 2013) |
Ellen L. Janos ~ Mintz, Levin, Cohn, Ferris, Glovsky andPopeo, P.C.
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| Chapter 12: Five Takeaways from the OIG’s Special Advisory Bulletin on Exclusion |
Karen Lovitch ~ Mintz, Levin, Cohn, Ferris, Glovsky andPopeo, P.C.
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| Index |
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