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Health Care and Life Sciences Law 2014

Practice Area: Health care, Life sciences, Litigation, Pharmaceuticals

Published: Oct 2014 i Other versions can be found in the Related Items tab.
ISBN: 9781402423192
PLI Item #: 48141
CHB Spine #: M5

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Front Matter
Faculty Bios
Table of Contents
Chapter 1. Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 (Draft Guidance, February 2012)
Chapter 2. FDA Accepts First Biosimilar Application Under New Approval Pathway (July 29, 2014)
Chapter 3. Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff (September 25, 2013)
Chapter 4. Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices: Draft Guidance for Industry and Food and Drug Administration Staff (Draft Guidance)
Chapter 5. Examples of MMAs the FDA Has Cleared or Approved
Chapter 6. FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework (April 2014)
Chapter 7. Title II of the Drug Quality and Security Act: Drug Supply Chain Security
Chapter 8. Drug Supply Chain Security Act (DSCSA) Implementation Plan
Chapter 9. Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format; Establishment of a Public Docket (Docket No. FDA–2014–N–0200)
Chapter 10. FDA Notified Congress of Its Plan to Issue Draft Guidances Describing Regulatory Framework for Laboratory Developed Tests (August 21, 2014)
Chapter 11. FDA Issues Final Guidance on “In Vitro Companion Diagnostic Devices” (August 18, 2014)
Chapter 12. FDA Issues Two Draft Guidance Documents Concerning Internet/Social Media Platforms
Chapter 13. Guidance for Industry: Fulfilling Regulatory Requirements for Postmarking Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics (Draft Guidance, January 2014)
Chapter 14. Repealing and Replacing the SGR (February 6, 2014)
Chapter 15. Preliminary Design for an Oncology-Focused Model
Chapter 16. Accountable Care Organizations: What Providers Need to Know (April 2014)
Chapter 17. Hospital Value-Based Purchasing Program: Frequently Asked Questions (March 9, 2012)
Chapter 18. CMS Has a Variety of Quality Reporting and Performance Programs (PowerPoint slides)
Chapter 19. Alleged FCA Violations Commonly Asserted Against Health Care Entities
Chapter 20. Second Circuit Recognizes Significant First Amendment Protections for Off-Label Promotion
Chapter 21. New Health Care Delivery Models: State Regulatory Challenges (August 25, 2014)
Chapter 22. Recommended Compliance Resources
Chapter 23. A Toolkit for Health Care Boards
Chapter 24. Publication of OIG Compliance Program Guidance for Clinical Laboratories
Chapter 25. OIG Compliance Program Guidance for Pharmaceutical Manufacturers
Chapter 26. Publication of the OIG’s Compliance Program Guidance for Medicare+Choice Organizations Offering Coordinated Care Plans
Chapter 27. Publication of the OIG Compliance Program Guidance for Hospitals
Chapter 28. OIG Supplemental Compliance Program Guidance for Hospitals
Chapter 29. Guidance for Submitting a Contractor Self-Disclosure (April 2014)
Chapter 30. OIG’s Provider Self-Disclosure Protocol (Updated, April 17, 2013)
Chapter 31. CMS Voluntary Self-Referral Disclosure Protocol (OMB Control Number: 0938-1106)
Index

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