2016 Year-End Report

February 24, 2017

The Ever-Changing World of Life Sciences

We at Porzio Life Sciences (“PorzioLS”) have been a leading resource for the life sciences industry for over 12 years. As such, we have been front and center for the exciting changes that continue to drive the evolution of the industry. We proudly offer the 2016 Porzio Life Sciences Year-End Report as an overview of many of the year’s key events.

Topics include:

  • Licensing and Distribution
    • Drug Stewardship Programs
    • New Massachusetts Legislation
    • Implementing the Drug Supply Chain Security Act
    • Making Moves: Update on Third-Party Logistics Provider Licensing
    • The Logistics: Key Changes
    • New Jersey Enacts Legislation Clarifying Licensing Requirements
    • New Jersey Proposes Legislation to Restrict the Provision of Discounts, Rebates, or Product Vouchers
  • Enforcement Actions
    • PhRMA and BIO Published Principles of Off-Label Communication
    • FDA Public Hearing on Off-Label Communication
    • OIG Final Rules on Anti-Kickback Safe Harbors and Civil Monetary Penalties
    • FDA’s Office of Prescription Drug Promotion
  • International Transparency
    • A Milestone Moment for the Global Transparency Movement
    • EFPIA 2016 Overall Total Spend by Country
    • 2017 Projected Reporting Dates by Country
    • Porzio GST
  • Mid-Level Regulations
    • Key Changes for Mid-Level Professionals
  • U.S. Transparency and Limitations
    • Sunshine Act Statistics: 2015 Open Payments Data
    • Price and Cost Transparency
    • Chicago Adopts Licensing Ordinance for Pharmaceutical Representatives
    • The New Kid on the Block: The First Disclosure Reports for Connecticut Will Be Filed in 2017
    • D.C. Introduces Temporary and Emergency Legislation to Amend the Pharmaceutical Detailer Licensure Exemption

To read the full report, please click here.

We hope that this report serves as a useful reference of 2016 key events, and provides meaningful, practical information to you and your company. 

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