Course Handbook  Course Handbook

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

Publication Date: October 2017 Number of Volumes: 1
ISBN Number: 9781402429965 Page Count: 628 pages

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Download: Table of Contents    Index

Table of Contents
Chapter 1: FDA Offers Some Clarity (But Few Concessions) on Off-Label Communication of Medical Products (January 27, 2017) Nathan A Brown ~ Akin Gump Strauss Hauer & Feld LLP
Chapter 2: Senate Passes Long-Awaited FDA User Fee Package (August 4, 2017) Nathan A Brown ~ Akin Gump Strauss Hauer & Feld LLP
Chapter 3: 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
Chapter 4: Digital Health Innovation Action Plan Scott D Danzis ~ Covington & Burling LLP
Chapter 5: FDA Initiates Software Precertification Pilot Program (August 3, 2017) Scott D Danzis ~ Covington & Burling LLP
Chapter 6: FDA Releases Details and Timelines in Its Digital Health Innovation Action Plan (August 3, 2017) Scott D Danzis ~ Covington & Burling LLP
Chapter 7: H.R. 2430—115th Congress: FDA Reauthorization Act of 2017 (August 14, 2017)
Chapter 8: European Union Robin Blaney ~ Covington & Burling LLP
Grant Castle ~ Covington & Burling LLP
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 Kathy O’Connor ~ Sills Cummis & Gross P.C.
Robert P Reznick ~ Sills Cummis & Gross P.C.
Chapter 13: Effective Compliance Programs and Investigations (November 2, 2016) Laura F Laemmle-Weidenfeld ~ Jones Day
T. Reed Stephens ~ McDermott Will & Emery LLP
Chapter 14: Effective Compliance Programs: Ensuring Your Client Is Protected/Internal Investigations: A Hypothetical Laura F Laemmle-Weidenfeld ~ Jones Day
Chapter 15: OIG Compliance Program Guidance for Pharmaceutical Manufacturers
Chapter 16: Practical Guidance for Health Care Governing Boards on Compliance Oversight
Index

This Course Handbook was compiled for the program, Life Sciences 2017 Navigating Legal Challenges in the Drug and Device Industries.

PLI’s nationally acclaimed course handbooks represent the definitive thinking of the nation’s finest legal minds on timely topics and are considered the standard reference in the field. This course handbook is prepared specifically for the program and stands alone as a permanent reference.

Chairperson(s)
Nathan A Brown, Akin Gump Strauss Hauer & Feld LLP
Scott D Danzis, Covington & Burling LLP
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