Course Handbook  Course Handbook

Life Sciences 2016: Navigating Legal Challenges in the Drug and Device Industries

Publication Date: November 2016 Number of Volumes: 1
ISBN Number: 9781402427794 Page Count: 652 pages

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Table of Contents
Chapter 1: Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Public Hearing; Request for Comments, Department of Health and Human Services, Food and Drug Administration, 21 CFR Part 15 (September 1, 2016) Scott D Danzis ~ Covington & Burling LLP
Chapter 2: FDA Publishes Two Draft Guidances on Next Generation Sequencing Technology (July 18, 2016) Ellen J Flannery ~ Covington & Burling LLP
Scott D Danzis ~ Covington & Burling LLP
Chapter 3: FDA Publishes Draft Guidance on Codevelopment of Companion Diagnostics (August 2, 2016) Scott D Danzis ~ Covington & Burling LLP
Chapter 4: Amarin Pharma, Inc., Dr. Jonathan Herbst, Dr. Eric Rishe, Dr. Peter Gottesfeld, and Dr. Ralph Yung v. United States Food & Drug Administration, United States of America, Stephen Ostroff, M.D., and Sylvia Matthews Burwell, Case 1:15-cv-03588-PAE (S.D.N.Y. 2015) Scott D Danzis ~ Covington & Burling LLP
Chapter 5: Pacira Pharmaceuticals, Inc., Dr. Loren J. Harris, and Dr. Joseph W. Bell v. United States Food & Drug Administration; United States of America; Dr. Stephen Ostroff, United States Department of Health & Human Services, and Sylvia Mathews Burwell, Stipulation and Order, Case 1:15-cv-07055-LAK (S.D.N.Y. 2015) Scott D Danzis ~ Covington & Burling LLP
Chapter 6: Memo to The Honorable Sylvia Burwell from Committee on Energy and Commerce (May 26, 2016) Scott D Danzis ~ Covington & Burling LLP
Chapter 7: Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Product (Draft Guidance) (January 2015) Nathan A Brown ~ Akin Gump Strauss Hauer & Feld LLP
Chapter 8: Guidance for Industry and FDA Staff: Classification of Products as Drugs and Devices & Additional Product Classification Issues (Draft Guidance) (June 2011) Nathan A Brown ~ Akin Gump Strauss Hauer & Feld LLP
Chapter 9: Draft Guidance for Industry and Food and Drug Administration Staff: Medical Device Reporting for Manufacturers (Draft Guidance) (July 9, 2013) Nathan A Brown ~ Akin Gump Strauss Hauer & Feld LLP
Chapter 10: Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients (Minority Staff Report) (January 2016) Nathan A Brown ~ Akin Gump Strauss Hauer & Feld LLP
Patty Murray ~ United States Senate, Health, Education, Labor, and Pensions Committee
Chapter 11: Medicaid Drug Rebate Program Notice for Participating Drug Manufacturers (July 14, 2016) John Siracusa ~ Akin Gump Strauss Hauer & Feld LLP
Chapter 12: Medicare Program; Part B Drug Payment Model; Proposed Rule, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 42 CFR Part 511 (March 2016) John Siracusa ~ Akin Gump Strauss Hauer & Feld LLP
Chapter 13: Notice of Proposed Rulemaking for Bundled Payment Models for High-Quality, Coordinated Cardiac and Hip Fracture Care (July 25, 2016) John Siracusa ~ Akin Gump Strauss Hauer & Feld LLP
Chapter 14: Medicare Clinical Diagnostic Laboratory Tests Payment System Final Rule (June 17, 2016) John Siracusa ~ Akin Gump Strauss Hauer & Feld LLP
Chapter 15: Anti-Corruption Enforcement: What to Watch in 2016 (Winter 2016) Jennifer Saperstein ~ Covington & Burling
Chapter 16: Mitigating FCPA Risk: The Critical Role of Due Diligence in M&A and Joint Ventures Howard L Dorfman ~ H. L. Dorfman Pharmaceutical Consulting, LLC
Chapter 17: Specific FDA Enforcement Tools Robert P Reznick ~ Sills Cummis & Gross P.C.
Chapter 18: The Foreign Corrupt Practices Act and Its Impact on the Pharmaceutical Industry Anne Elkins Murray ~
Guy David Singer ~
Joshua C Foster ~
Robert P Reznick ~ Sills Cummis & Gross P.C.
Chapter 19: Huge Stark Law Hospital Settlements and Physician Culpability—The New Normal Post-Tuomey? T. Reed Stephens ~ McDermott Will & Emery LLP
Tony Maida ~ McDermott Will & Emery LLP
Chapter 20: Effective Compliance Programs and Investigations (PowerPoint slides) Laura F Laemmle-Weidenfeld ~ Jones Day
T. Reed Stephens ~ McDermott Will & Emery LLP
Chapter 21: Effective Compliance Programs: Ensuring Your Client is Protected/Internal Investigations: A Hypothetical Laura F Laemmle-Weidenfeld ~ Jones Day
Chapter 22: Department of Health and Human Services, Office of Inspector General, OIG Compliance Program Guidance for Pharmaceutical Manufacturers Laura F Laemmle-Weidenfeld ~ Jones Day
Chapter 23: Practical Guidance for Health Care Governing Boards on Compliance Oversight Laura F Laemmle-Weidenfeld ~ Jones Day
Chapter 24: The Health Care Industry and DOJ’s New Corporate Conduct Enforcement Guidelines T. Reed Stephens ~ McDermott Will & Emery LLP
Michael W Peregrine ~ McDermott Will & Emery
Index

This Course Handbook was compiled for the program, Life Sciences 2016 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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