Category Archives: Policy News

Sumitomo Pharma Oncology, Inc. (SMP Oncology) and Steve Warner, Ph.D., Senior Vice President and Head of US Research at SMP Oncology, were recently featured in a Pharma Tech Outlook. In “Sumitomo Pharma Oncology: Discovering Immunotherapy Agents with Persistence,” Dr. Warner discusses SMP Oncology’s ongoing work in immunotherapy drug discovery, highlighting the progress with the Company’s […]

BioUtah has established a partnership with Invest Lithuania, an arm of the Lithuanian government focused on developing life sciences in their country. The life sciences sector in Lithuania is regarded as one of the most highly developed in Central and Eastern Europe (CEE). The sector is driven by innovation and aims to become Europe’s next […]

Bipartisan Agreement Will Support Innovation, Lower Costs, and Improve People’s Lives Washington, D.C. – Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ), Ranking Member Cathy McMorris Rodgers (R-WA), Health Subcommittee Chairwoman Anna G. Eshoo (D-CA), and Health Subcommittee Ranking Member Brett Guthrie (R-KY) today unveiled a comprehensive legislative package to reauthorize the Food and Drug […]

The FDA and representatives from the medical device industry have reached an agreement on proposed recommendations for MDUFA V. On March 22, FDA sent the commitment letter to Congress. Under the new agreement, the FDA would be authorized to collect at least $1.78 billion in user fees over five years. FDA could receive additional funding […]

Over the last couple of weeks, health legislative staff for Utah Reps. Chris Stewart (R-UT) and John Curtis (R-UT) have been touring a number of the state’s life sciences companies to learn more about their innovative work and our growing BioHive.  Colleen Malloy White, on behalf of Curtis, visited IONIQ Sciences, ARUP Laboratories and ATL […]

To help fight the pandemic, the FDA has been issuing EUAs and exercising enforcement discretion for medical devices needed to diagnose, treat, or prevent COVID-19. Last month, the agency issued two draft guidances related to transition plans to regular compliance for COVID-19 related medical devices that fall under EUAs or Agency Enforcement Policies that have […]