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.