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Life Sciences 2019: Navigating Legal Challenges in the Drug and Device Industries

Chair(s): Nathan A. Brown, Scott D. Danzis
Practice Area: Health Care, Insurance, Intellectual Property
Published: Oct 2019
ISBN: 9781402434860
PLI Item #: 253903
CHB Spine #: M22

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Front Matter
Faculty Bios
Table of Contents
Chapter 1. 2018 End-of-Year Summary of FDA Advertising and Promotion Enforcement Activity (January 31, 2019)
Chapter 2. FDA Outlines Proposed Framework for Regulating Artificial Intelligence Software (April 10, 2019)
Chapter 3. FDA Advertising and Promotion Enforcement Activities: Update (March 14, 2019)
Chapter 4. Insurance Coverage for Opioid Lawsuits and Investigations (January 17, 2018)
Chapter 5. Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products Guidance for Industry: Draft Guidance (December 2018)
Chapter 6. FDA Statement on Court Ruling Related to Compounded Bulk Drug Substances and the Agency’s Ongoing Efforts to Implement Its Compounding Authorities (August 6, 2019)
Chapter 7. Opioid Medications
Chapter 8. Healthy Innovation, Safer Families: FDA’s 2018 Strategic Policy Roadmap (January 2018)
Chapter 9. FDA’s AI White Paper: To Be or Not to Be, That Is the Question
Chapter 10. Artificial Intelligence and Machine Learning in Software as a Medical Device
Chapter 11. Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)–Based Software as a Medical Device (SaMD): Discussion Paper and Request for Feedback
Chapter 12. Drug Pricing Legislation and Administrative Actions (August 7, 2019)
Chapter 13. Senate HELP Committee and House Energy and Commerce Committee Surprise Billing Proposals (August 7, 2019)
Chapter 14. Drug Pricing and Surprise Billing: Recent Actions and Outlook (August 7, 2019)
Chapter 15. DOJ Files Amicus Brief Declaring Intention to Dismiss FCA Case
Chapter 16. DOJ Issues New FCA Guidance on Cooperation Credit
Chapter 17. EHR Vendor to Pay $57 Million to Settle FCA Case
Chapter 18. Federal Government Agrees to Global $260M Settlement with Florida Hospital Chain
Chapter 19. Walgreens Pays $269.2 Million to Settle Fraud Allegations
Chapter 20. 2019 Program Audit Process Overview (November 2018)
Chapter 21. 2019 Program Audits
Chapter 22. Fact Sheet: Trump Administration Proposes to Lower Drug Costs by Targeting Backdoor Rebates and Encouraging Direct Discounts to Patients
Chapter 23. Laura F. Laemmle-Weidenfeld, Daniel A. Cody and Taylor A. Goodspeed, Certain Pharmaceutical Discounts No Longer Safe under the “Safe Harbors”?
Chapter 24. Proposed Rule: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees, 42 CFR Part 1001, 84 Fed. Reg. 2340, No. 25 (February 6, 2019)
Index

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