2015 Year-End Report

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.