Dive into Facet Life Sciences’ blog for expert articles and insights on regulatory trends, scientific developments, and industry news.
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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