Course Handbook  Course Handbook

Life Sciences 2018: Navigating Legal Challenges in the Drug and Device Industries

Publication Date: November 2018 Number of Volumes: 1
ISBN Number: 9781402432651 Page Count: 312 pages

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Download: Table of Contents    Index

Table of Contents
Chapter 1: Draft Guidance for Industry and Food and Drug Administration Staff (December 8, 2017)
Chapter 2: Scott Gottlieb, FDA’s Comprehensive Effort to Advance New Innovations: Initiatives to Modernize for Innovation (August 29, 2018) Nathan A. Brown ~ Akin Gump Strauss Hauer & Feld LLP
Chapter 3: Health Industry Alert (January 2, 2018) Nathan A. Brown ~ Akin Gump Strauss Hauer & Feld LLP
Chapter 4: Digital Health Checkup: Key Questions Market Players Should Be Asking (Part One) (August 29, 2017) Scott D. Danzis ~ Covington & Burling LLP
Chapter 5: Digital Health Checkup (Part Two): Key Commercial Questions When Contracting for Digital Health Solutions (September 26, 2017) Scott D. Danzis ~ Covington & Burling LLP
Chapter 6: Digital Health Checkup (Part Three): Key Questions About AI, Data Privacy, and Cybersecurity (December 5, 2017) Scott D. Danzis ~ Covington & Burling LLP
Chapter 7: FDA Outlines Updated Approach to Regulating Digital Health Technologies (December 20, 2017) Scott D. Danzis ~ Covington & Burling LLP
Chapter 8: ICO Consults on Privacy “Regulatory Sandbox” (September 17, 2018) Scott D. Danzis ~ Covington & Burling LLP
Chapter 9: European Union Robin Blaney ~ Covington & Burling
Grant Castle ~ Covington & Burling LLP
Chapter 10: Draft Memorandum of Understanding Addressing Certain Distributions of Compounded Drug Products Between the State [insert STATE] and the U.S. Food and Drug Administration Nathan A. Brown ~ Akin Gump Strauss Hauer & Feld LLP
Chapter 11: American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (May 2018) Nathan A. Brown ~ Akin Gump Strauss Hauer & Feld LLP
Chapter 12: FDA Releases Revised Memorandum of Understanding That Would Ease Restrictions on Interstate Shipment of Compounded Drugs (September 10, 2018) Nathan A. Brown ~ Akin Gump Strauss Hauer & Feld LLP
Chapter 13: Statement from FDA Commissioner Scott Gottlieb, M.D., on New Steps to Help Ensure the Quality of and Preserve Access to Compounded Drugs by Pursuing Closer Collaboration with States (September 7, 2018) Nathan A. Brown ~ Akin Gump Strauss Hauer & Feld LLP
Chapter 14: Trump Administration Drug Pricing Blueprint: Overview and Analysis (May 15, 2018) Nathan A. Brown ~ Akin Gump Strauss Hauer & Feld LLP
Chapter 15: Daniel A. Kracov, Mahnu Davar and Abraham Gitterman, Ch. 13: Enforcement and Government Investigations Relating to Medical Devices, Practising Law Institute, Medical Devices Law and Regulation Answer Book (2019 Edition)
Index

This Course Handbook was compiled for the program, Life Sciences 2018 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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