Dive into Facet Life Sciences’ blog for expert articles and insights on regulatory trends, scientific developments, and industry news.
Radiopharmaceuticals present a distinct set of development and regulatory challenges. These agents can be used for both diagnostic imaging and targeted radiotherapy. They combine radioactive isotopes with pharmaceutical and bio...
Insights from the “Tinker to Treasure” Webinar The development of radiopharmaceuticals offers tremendous potential for both the diagnosis and treatment of disease. However, turning early-stage research into a market-ready produ...
By Tom Hallam, Ph.D., MBA For small pharma companies navigating the road to US market approval, the right nonclinical regulatory strategy, built with expert consulting and scientific guidance, can mean the difference between ef...
When preparing for a meeting with the FDA, most Sponsors focus on regulatory affairs, clinical leads, or medical officers. However, one role that is becoming increasingly central and often overlooked is the statistician. Whethe...
by Lisa Jenkins VanLuvanee, Ph.D. For small biotech and medical device companies without internal regulatory experts, knowing whether you’re getting the right advice can be a real challenge. In this interview, Dr. Lisa Je...
By Dr. Randy Goodman Ph.D., MHA, FACHE, PMP, BCMAS HEOR stands for Health Economics and Outcomes Research. It is a science that combines health economics, which focuses on the allocation of healthcare resources, and outcomes re...
by Dr. Jason Mercer, Ph.D., RAC and Strategic Program Innovator FDA’s Breakthrough Therapy Designation (BTD) program offers sponsors a powerful opportunity to expedite development of promising therapies for serious or life-thr...
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