"Prepared for distribution at the Life Sciences 2018: navigating legal challenges in the drug and device industries Program, New York City, November 16, 2018"--Page 5. "#220430"--Back Cover. Includes bibliographical references and index.
Contents:
Practical Guidance for Health Care Governing Boards on Compliance Oversight Laura F Laemmle Weidenfeld Jones Day -- Senate Passes Long Awaited FDA User Fee Package (August 4, 2017) / Nathan A Brown Akin Gump Strauss Hauer & Feld LLP -- The 21st Century Cures Medical Software Provisions: Additional Clarity for Digital Health, but Also More Questions (January 3, 2017) / Nathan A Brown Akin Gump Strauss Hauer & Feld LLP -- Digital Health Innovation Action Plan / Scott D Danzis Covington & Burling LLP -- FDA Initiates Software Precertification Pilot Program (August 3, 2017) / Scott D Danzis Covington & Burling LLP -- FDA Releases Details and Timelines in Its Digital Health Innovation Action Plan (August 3, 2017) / Scott D Danzis Covington & Burling LLP -- H.R. 2430 115th Congress: FDA Reauthorization Act of 2017 (August 14, 2017) -- European Union / Robin Blaney Covington & Burling LLP Grant Castle Covington & Burling LLP -- 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 -- 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) -- Medicare Program; Medicare Clinical Diagnostic Laboratory Tests Payment System; Final Rule (June 23, 2016) -- Specific FDA Enforcement Tools -- Effective Compliance Programs and Investigations (November 2, 2016) / Laura F Laemmle Weidenfeld Jones Day T. Reed Stephens McDermott Will & Emery LLP -- Effective Compliance Programs: Ensuring Your Client Is Protected/Internal Investigations: A Hypothetical / Laura F Laemmle Weidenfeld Jones Day -- OIG Compliance Program Guidance for Pharmaceutical Manufacturers -- Practical Guidance for Health Care Governing Boards on Compliance Oversight
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