Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from colleagues in other related life science disciplines.
PhRMA Code Changes Are on the Horizon: Is Your Company-Sponsored Speaker Program Ready?
By: Jennifer D. Burgar & Genevieve M. Razick
In August 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced an updated and enhanced PhRMA Code on Interactions with Healthcare Professionals (PhRMA Code). The revisions apply to the PhRMA Code’s principles applicable to company-sponsored speaker programs. The changes will go into effect on January 1, 2022. More >
What You Need to Know: Mitigating Risk During A Medtech Deal
By: Lori L. Wright & Eunice C. Lim
Over the past decade, M&A activity has been steadily trending upward, paused only momentarily in 2020 by global pandemic concerns. Although activity is heavy across many sectors, there is particular interest and investment in medical technology (“medtech”). Despite the pandemic, in 2020, over 100 medical tech M&A deals were closed worldwide. Although the FDA’s regulatory reach extends only to medical devices, in recent public comments, FDA officials have signaled an interest in increasing their enforcement abilities to include software that does not meet the definition of a device, but which supports or is relied on by devices. These overtures, paired with increased national attention on cybersecurity and resiliency, give rise to unique and constantly evolving legal concerns. More >
A Shot in the Arm: New Biden Administration Rules Mandate Vaccinations or Frequent Testing In Numerous Employment Settings
By: Henry M. Perlowski & Thomas E. Kelly
On September 9, 2021, President Biden announced a sweeping action plan to address the ongoing COVID-19 pandemic in the United States, entitled The Path Out of the Pandemic. This plan is based on six pillars identified by the Biden Administration as critical to combating the COVID-19 pandemic, including: i) federal vaccination and testing mandates applicable to both public and private sector employees; ii) booster shots for the vaccinated population; iii) increased testing and masking requirements; iv) facilitation of further economic recovery; v) ensuring that schools remain open; and vi) improving care for those impacted by the COVID-19 virus. More >