2015 Year-End Report

February 24, 2016

Navigating the Regulatory Landscape

Porzio Life Sciences ("PorzioLS") has been a leading resource for the life sciences industry for over 11 years. The 2014 Year-End Report was the first annual PorzioLS accounting of the headlines and emerging trends of the prior year. Continuing in this vein, we proudly offer the 2015 Year-End Report: Navigating the Regulatory Landscape.

Topics include:

  • Distribution & Licensing
    • Track and Trace Requirements for Wholesalers, Manufacturers and Repackagers
    • Wholesaler and 3PL Licenses Reporting
    • Massachusetts Alternatives to Sampling
    • Medical Device Excise Tax
  • Enforcement Actions
    • OPDP Enforcement Letters
    • FDA Guidances Regarding Drug Promotion
    • Government Prosecutions: Major Settlements
    • Pharmaceutical Companies vs. The FDA
  • International Transparency
    • Ready or Not: Make Way for the Global Transparency Movement
    • Key 2015 Ex-US Events
    • 2016 International Reporting Deadlines
  • Mid-Level Regulations
    • Key Changes to Mid-Level Regulations in 2015
    • The APRN Independence Movement
  • US Transparency
    • Sunshine Act Changes Affecting 2016 Data
    • Pending Legislation to Amend the Sunshine Act
    • State Legislation Requiring the Reporting of Marketing and Advertising Costs

To read the full report, please click here.

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