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Life Sciences 2015: Navigating Legal Challenges in the Drug and Device Industries
Chair(s):
Scott D. Danzis, Nathan A. Brown
Practice Area:
Health Care
Published:
Oct 2015
ISBN:
9781402425547
PLI Item #:
59180
CHB Spine #:
M7
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Table of Contents
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Front Matter
Faculty Bios
Table of Contents
Chapter 1. 2014 End-of-Year Summary of FDA Promotional Enforcement Activity (August 11, 2015)
Chapter 2. Subtitle L—Priority Review for Breakthrough Devices
Chapter 3. FDA Notified Congress of Its Plan to Issue Draft Guidances Describing Regulatory Framework for Laboratory Developed Tests
Chapter 4. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff (October 2, 2014)
Chapter 5. General Wellness: Policy for Low Risk Devices: Draft Guidance for Industry and Food and Drug Administration Staff, Draft Guidance (January 20, 2015)
Chapter 6. Guidance for Industry: Expedited Programs for Serious Conditions—Drugs and Biologics
Chapter 7. Guidance for Industry and Food and Drug Administration Staff: Priority Review of Premarket Submissions for Devices (May 17, 2013)
Chapter 8. Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff (February 9, 2015)
Chapter 9. OIG Releases New Proposals on Anti-kickback Statute Safe Harbors, Exceptions to the CMP Law and the Gainsharing Prohibition (October 10, 2014)
Chapter 10. Food and Drug Administration Approval of First Biosimilar Product
Chapter 11. Better Care. Smarter Spending. Healthier People: Paying Providers for Value, Not Volume
Chapter 12. Specific FDA Enforcement Tools
Chapter 13. The Foreign Corrupt Practices Act and Its Impact on the Pharmaceutical Industry
Chapter 14. Trends and Developments in Anti-Corruption Enforcement (Winter 2015)
Chapter 15. Practical Guidance for Health Care Governing Boards on Compliance Oversight
Chapter 16. OIG Compliance Program Guidance for Pharmaceutical Manufacturers
Chapter 17. Effective Compliance Programs and Investigations (PowerPoint slides)
Chapter 18. Effective Compliance Programs: Ensuring Your Client Is Protected/Internal Investigations: A Hypothetical
Index
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