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

Chair(s): Scott D. Danzis, Nathan A. Brown

Practice Area: Life sciences, Medical devices, Pharmaceuticals

Published: Nov 2018 i Other versions can be found in the Related Items tab.
ISBN: 9781402432651
PLI Item #: 220430
CHB Spine #: M18

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Front Matter
Faculty Bios
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 Draft Guidance for Industry and Food and Drug Administration Staff (December 8, 2017)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)
Chapter 3. Health Industry Alert (January 2, 2018)
Chapter 4. Digital Health Checkup: Key Questions Market Players Should Be Asking (Part One) (August 29, 2017)
Chapter 5. Digital Health Checkup (Part Two): Key Commercial Questions When Contracting for Digital Health Solutions (September 26, 2017)
Chapter 6. Digital Health Checkup (Part Three): Key Questions About AI, Data Privacy, and Cybersecurity (December 5, 2017)
Chapter 7. FDA Outlines Updated Approach to Regulating Digital Health Technologies (December 20, 2017)
Chapter 8. ICO Consults on Privacy “Regulatory Sandbox” (September 17, 2018)
Chapter 9. European Union
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
Chapter 11. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (May 2018)
Chapter 12. FDA Releases Revised Memorandum of Understanding That Would Ease Restrictions on Interstate Shipment of Compounded Drugs (September 10, 2018)
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)
Chapter 14. Trump Administration Drug Pricing Blueprint: Overview and Analysis (May 15, 2018)
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

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